RP

Regeneron Pharmaceuticals

20 open positions available

10 locations
1 employment type
Actively hiring
Full-time

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RP

Director, Product Management, Delivery & Operations

Regeneron PharmaceuticalsWarren, Michigan, Armonk, New YorkFull-time
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Compensation$100K - 140K a year

Lead teams to deliver, maintain, and improve technology products while managing stakeholders, product backlogs, and operational support. | Bachelor's degree with over 10 years of experience in development operations and portfolio management, strong communication, and project and budget management skills. | The Global Development IT Director, Product Management is a key member of the GDIT Delivery & Operations organization, responsible for overseeing and guiding their team members in delivering, maintaining & enhancing all technology products in their defined business domain. This resource will also partner with key business stakeholders to intake, design, implement and enhance technology products. This role will work closely with Business Solution Partners (BSP) to deliver projects and technology product improvements. The role will also be responsible for line management of product owners aligned to the domain and will assume product owner responsibilities for a specific set of technologies, including end-to-end implementation and support for all products that fall within the domain. This role will be responsible for the Development Operations & Portfolio Management (DO&PM) domain. The role will be based onsite at our offices in Warren, NJ or Armonk, NY. This is not open to fully remote-based work arrangements. If eligible, we can offer relocation benefits. In this role, a typical day might include the following: Lead & coach the Product Leads and Product Analysts within GDIT Delivery & Operations assigned to the domain, ensuring delivery on team commitments, collaboration across members, and definitions of processes, tools and competencies needed to further build the domain capabilities. Oversee all operational support for products and domain providing line leadership and guidance to individual product owners while thinking across product lines. Ensure alignment with product model processes and standards while customizing to meet domain-specific needs as applicable, including being responsible for product backlog and incidents management, including insights into enhancements and incidents trends over time. Partner with the Business Process Owners and BSPs to implement new/enhanced technologies, and take ownership of products including end-to-end support, performance, and commitment to continuous improvement. Intake, assess, prioritize and validate domain specific needs/requirements including partnership with BSPs to ensure alignment between technology roadmaps and product priorities. Responsible for identifying resourcing needs and for oversight of internal and vendor delivery, and managed service vendor associates in support of product. Work collaboratively with GDS functions, Corporate IT, and other relevant functions in the management of enterprise systems, including development and adherence to standards and governance. This Job Might Be For You If You Have: Proven ability to manage competing priorities across a multitude of stakeholders and to direct teams to deliver value-oriented, prioritized solutions. Excellent communication skills and the ability to indirectly influence key partners and stakeholders with clear, concise, and well-formed message tailored to the audience Strong record of accomplishment in technology project management, stakeholder management, budget management and value engineering. Ability to effectively manage multiple priorities with a sense of urgency, and effectively manage ambiguity and changing priorities Experience managing technology capability identification, selection, implementation, and operations Excellent problem-solving skills to address day-to-day challenges associated with business solutions Knowledge of pharmaceutical Global Development business capabilities, processes, systems, and key trends in the industry. Experience growing and motivating a team, coaching members through career milestones and progression. Exposure to delivering presentations and engaging with senior leadership. To be considered for this role, you must have: BS/BA Degree with 12+ years relevant experience MS Degree with 10+ years relevant experience Deep knowledge of Development Operations & Portfolio Management business processes, including but not limited to Drug Development Program and Portfolio Management; Resource Management; Clinical Trial Feasibility, Planning, Execution, and Closeout; Clinical Monitoring; Study Start-up; Site Management; and Clinical Drug Supply Management. Experience managing technology teams and driving business value in the Clinical Operations space with specific technologies like Veeva Clinical Vault (CTMS, TMF, SSU, etc.), CluePoints, Planisware, etc., a plus. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $183,100.00 - $305,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Vendor Management
Sales Operations
Agile/Scrum Methodologies
Stakeholder Management
Direct Apply
Posted 19 days ago
RP

Director PPM Data Stewardship Lead

Regeneron PharmaceuticalsTarrytown, Georgia, Warren, MichiganFull-time
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Compensation$120K - 160K a year

Lead enterprise data stewardship function to define vision, strategy, and operating model ensuring data integrity and consistency. | Bachelor's degree with 12+ years experience including 5+ years leadership, knowledge of drug development, project planning, and data management, plus proficiency in project planning software. | The Director Data Stewardship Lead (Director Level) is a strategic enterprise role responsible for establishing and leading the data stewardship function at the portfolio level. This individual will define the vision, strategy, and operating model for stewardship, ensuring data integrity, accessibility, and consistency to enable enterprise planning, portfolio insights, and informed decision-making. They will work closely with Data Governance, the key system Business Process Owner (e.g. Planisware, Planview), Portfolio Management, Program and Project Planning, DADS (Data Analytics & Data Science), and domain data owners to operationalize stewardship practices and embed robust data standards, quality frameworks, and analytical capabilities into the organization’s core operations. This role carries responsibility to build out and lead a team over time, enabling the maturation and scaling of the stewardship function. ***NOTE: This role must be onsite 4-days per week in either our Tarrytown, NY or Warren, NJ office and is NOT eligible remote. A typical day in this role: Establish and lead the data stewardship function, including defining the strategic vision, operating model, and foundational processes, with a roadmap to build and lead a dedicated team over time. Partner with Data Governance to build upon and implement enterprise-wide data policies, standards, and SOPs that support regulatory compliance and business objectives. Collaborate with system Business Process Owners and Program, Portfolio Management and Project Planning Lead to align stewardship practices with enterprise planning systems and processes. Work closely with DADS (Data Analytics & Data Science) to ensure stewardship activities support enterprise analytics, data products, and AI/ML initiatives. Curate and maintain business metadata (definitions, glossary terms, business rules) to promote consistent data understanding and usage across functional domains. Ensure the quality, integrity, and completeness of portfolio-level data (study/program timelines, resource, financial, and operational metadata), including definition of data quality metrics and remediation plans. Design and oversee development of dashboards and reports to monitor stewardship performance, operational data quality, and portfolio trends, enabling data-driven decision making. Lead data integration and migration initiatives, ensuring seamless alignment between legacy systems and enterprise data platforms. Champion a data-driven culture by developing training, guidance, and communication strategies that empower business users to adopt governed data practices. Continuously assess and integrate emerging technologies (e.g., AI/GenAI) to enhance metadata management, anomaly detection, and stewardship efficiency. This role may be for you if you have: Extensive knowledge of drug development, project planning, and data management, with expertise in implementing data governance policies and upholding data quality standards. Proficient in project planning and analytics software such as Planisware, Microsoft Project, OnePager, and Microsoft Office (Word, Excel, PowerPoint), including dashboard and report creation. Strong analytical, communication, and collaboration skills, with the ability to identify, report, and escalate risks, and convey complex data insights to diverse stakeholders. Experienced in managing and monitoring data quality processes, including validation, reconciliation, and continuous improvement across study, program, resource, and financial data. Skilled in designing and maintaining metrics, dashboards, and reports to track operational performance, resource utilization, and financial outcomes. Proven ability to provide training and guidance on data stewardship best practices, facilitate alignment on data standards, and support adoption of new data environments and tools. Committed to staying current with industry trends, regulatory requirements, and emerging technologies to enhance data stewardship and analytics capabilities. In order to be considered qualified for this role, a minimum of a Bachelors Degree and 12+ years in data management, analytics, resource management, or related roles, with at least 5 years in a leadership or strategic capacity Data management or governance certifications (e.g., CDMP) and/or PMI Project Management Professional (PMP) is preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $183,100.00 - $305,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Data Governance
Portfolio Management
Data Integration
AWS Cloud
Technical Architecture
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Posted 19 days ago
RP

Director, Field Medical Affairs Training-Immunology & Inflammation

Regeneron PharmaceuticalsAnywhereFull-time
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Compensation$120K - 160K a year

Lead therapeutic area training and resource development for Immunology and Inflammation Field Medical Affairs, collaborating with partners to create and deliver training programs. | Advanced medical or scientific degree with 10+ years in Medical Affairs, including 5+ years in Immunology and Inflammation pharmaceuticals and experience in adult training and program development. | As a Director, you will lead our therapeutic area training and new resource development for Immunology and Inflammation Field Medical Affairs. You will collaborate with cross-functional partners, develop & deliver engaging training programs (virtual and live) and expand medical content creation. You will also engage with APP External Experts in production of content for live, virtual, and digital training platforms and customer-facing resources. A typical day may include the following: • Co-lead creation & implementation of customized scientific communication materials. • Use innovative adult-learning principles and training constructs, build strategic and customized curricula for medical teams needs and emerging clinical data • Leads strategy & execution of ongoing customer facing medical scientific training via innovative content creation • Lead the teaching and presenting of medical and scientific concepts, developing, and implementing scientific training materials and cross functional pull-through. • Formats and approaches, including digital formats, interactive and dynamic formats, and modular content approach. • Develop ongoing training curricula reinforcing medical strategy and educational updates on emerging clinical data, disease state advancements and health systems priorities • Prepare, organize, and delivers an effective and engaging onboarding training experience for field medical new hires, resulting in fully prepared field medical deployment • Monitor Industry Medical Affairs standards and provide recommendations for process improvement, engagement innovation, training delivery and technology needs. • Apply innovative instructional design to optimize the training experience and meet the goals of adaptive adult learning principles This may be for you if you: • Have the ability to transform strategic imperatives and medical direction into training deliverables • Can demonstrate a track record for timely planning and execution of key initiatives, department priorities and project coordination • Collaborate well in a dynamic environment and enjoy working with different team members • Have knowledge & understanding of clinical priorities for different healthcare professionals • Want to have an impact on patient lives To be considered an Advanced medical and/or scientific degree (e.g., MD/DO, PhD, PharmD) and 10+ years’ experience in Medical Affairs or relevant area. Immunology and Inflammation pharmaceutical experience is required (5+ years experience is preferred). Experience in adult training and program development and management as well as knowledge of training techniques and modalities preferred. Field medical experience highly preferred, including MSL and Health Outcomes Liaison roles. Prior experience developing educational assets such as slide decks, FAQs or related MSL materials is preferred. Travel requirements: locally and regionally, up to 20% with overnight stays (e.g., KOL meetings, site locations, internal meetings, medical meetings, congresses and training). Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $205,000.00 - $341,600.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Medical Strategy
Medical Education
Scientific Communication
Curriculum Development
Adult Learning Principles
Cross-Functional Collaboration
Direct Apply
Posted 19 days ago
RP

Associate Director Global Medical Information Operations

Regeneron PharmaceuticalsAnywhereFull-time
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Compensation$70K - 110K a year

Lead strategic planning and execution of medical education and business growth initiatives. | Over 20 years of leadership in medical affairs and education with strategic and clinical expertise but no direct Medical Information Call Center experience or PharmD degree. | As an Associate Director, Global Medical Information (GMI) you will support GMI and our Operations Director by streamlining processes and enhancing strategic execution. Core responsibilities include supporting the Medical Information Call Center for medical inquiries and reporting requirements related to adverse events and product quality complaints. We will implement established medical affairs strategy, while maintaining adherence and compliance with departmental/company policies, procedures and all applicable regulations and industry standards. A typical day may include: • Ensure the contact center is equipped with the resources, training and guidance support for assigned products. • Partners with the MI Therapeutic Areas ensuring the call center delivers high-quality, scientifically accurate and compliant medical responses. • Coordinates global operational activities and supports implementation of process improvements to optimize efficiency. • Collaborate with GMI and partners to implement new MI platforms and technologies, including AI enabled solutions. • Apply your expertise related to med info systems, compliance/quality audits, and identifies operational efficiency related to department best practices. • Maintain well-documented, inspection-ready operational records to support internal audits and global health authority inspections. • Lead the development of advanced analytics dashboards and reporting templates (e.g., Power BI, Tableau) supporting metrics reporting, product insights, and congress‑related outcomes. • Monitors and analyzes MICC medical inquiry volume, trends, response quality and performance metrics • Provides ad-hoc support to therapeutic areas, including scientific review of materials ensuring balanced, accurate, evidenced-based content. • Supports the fulfillment of unsolicited medical information requests and manages the dissemination of approved medical materials. • Coordinates the communication and execution of regulatory label updates with the call center and therapeutic areas to ensure timely updates of MI documents in Veeva Med Comm. This may be for you if you: • Want to have an impact on patient lives • Enjoy working in a "rapid response" environment • Have a deep understanding of Medical Information and global health authority regulations • Can adapt to supporting multiple therapeutic areas To be considered you are required to have a Master’s in relevant scientific or healthcare fields. A PharmD is preferred. Your experience will need to include a minimum of 3 years of Medical Information Call Center experience with potential to lead and manage the contact center. Strong administrative, organizational, and project coordination and project management skills. Strong understanding of the global and US regulatory aspects of medical information, adverse events, and product complaints. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $157,200.00 - $256,600.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Strategic Planning
Medical Education
Business Development
Direct Apply
Posted 23 days ago
RP

Senior Manager, Clinical Lab Study Manager

Regeneron PharmaceuticalsWarren, Michigan, Armonk, New YorkFull-time
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Compensation$90K - 130K a year

Lead and develop teams to execute complex projects and operational strategies ensuring efficiency and compliance. | You have extensive leadership and project management experience but lack the specific pharmaceutical and clinical trial sample collection experience required. | The Senior Manager, Precision Medicine Clinical Laboratory Study Management (CLSM Senior Manager) will lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology (IO). In this role, you will be a key driver of precision medicine operational execution partnering with Precision Medicine Strategy Lead (PMSL), clinical study teams, data management (DM), Samples, Kits, Data, Logistics (SKDL), Clinical Laboratory Study Manager (CLSM), and Clinical Laboratory Project Management (CLPM) groups to deliver high-quality samples and data. Through strong cross functional collaboration and operational excellence, you will help ensure biomarker and non-biomarker strategies are executed seamlessly, enabling the translation of innovative science to medicines for patients. As a CLSM Senior Manager, a typical day may include the following: Clinical Trial Study Team Support Participates in cross-functional study teams and sub-teams across clinical and research departments Works with project manager and set-up manager of central/specialty lab and clinical study team to build lab database to address clinical trial sample collection needs, kits, testing and logistics Monitor’s acquisition of clinical trial samples (including human tissue, bone marrow aspirate, whole blood, plasma, serum, etc.) and ensure compliance with ICF permissions Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders working on ICF and other trial documents impacting samples and testing Support cross functional internal and external collaborators to manage and support the generation of high-quality laboratory data. Work closely with central lab and/or specialty lab project managers, clinical trial management team, and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Serves as CLSM subject matter expert contact for assigned therapeutic areas including IO. Allocates and prioritizes FSP CLSM and Sr. PMA resources within the assigned therapeutic program and studies. Manages FSP CLSM team for technical and operational support on their assigned therapeutic program and studies. Operational Support of Sample Analysis (Including Exploratory Analysis) Oversees Study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing Forecasts sample related operational costs and reviews invoices to ensure we are aligned with budget plans Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents Prepares RFPs, reviews and assess bids and SOWs for items related to samples and testing Provides guidance and trainings to vendors, collaborators and clinical sites on sample collection, processing, shipping, and storage Data Acquisition and Management Works closely with data management lead and SKDL to determine how sample and testing data will be captured, blinded and transferred for clinical trials. Enables transfer of sample/testing data from vendors through development and review of appropriate data transfer specification and related documents in collaboration with SKDL. Human Sample Management Flow and Compliance Provides guidance to clinical teams and clinical sites regarding collection and storage of samples acquired during clinical trials or other human sample acquisition projects Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF Collaborates with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used, and destroyed This role may be for you if: You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment. The CLSM Senior Manager will be responsible for day-to-day oversight of multiple CLSMs, including responsibility for coaching, mentoring and performance management ensuring applicable key trial level milestones are achieved on schedule. You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success. To be considered for this role, you must have a Bachelors, Minimum of 8 years pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams. Minimum of 5 years’ experience with Clinical Trials, focus on clinical sample collection. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested. We need a strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology. Demonstrated experience in stake holder management, leading internal and external meetings and solutioning skills. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $134,400.00 - $219,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Leadership
Project Management
Sales Operations
Digital Transformation
Agile/Scrum Methodologies
Direct Apply
Posted 23 days ago
RP

Director, Product Management, Delivery & Operations

Regeneron PharmaceuticalsWarren, Michigan, Armonk, New YorkFull-time
View Job
Compensation$90K - 130K a year

Lead and coach teams to meet commitments while managing operational support and partnering with stakeholders to enhance technology products. | Bachelor's degree with extensive experience in project management and technology implementations, but lacking specific Oracle ERP and clinical operations expertise. | The Global Development IT Director, Product Management is a key member of the GDIT Delivery & Operations organization, responsible for overseeing and guiding their team members in delivering, maintaining & enhancing all technology products in their defined business domain. This resource will also partner with key business stakeholders to intake, design, implement and enhance technology products. This role will work closely with Business Solution Partners (BSP) to deliver projects and technology product improvements. The role will also be responsible for line management of product owners aligned to the domain and will assume product owner responsibilities for a specific set of technologies, including end-to-end implementation and support for all products that fall within the domain. This role will be responsible for the Development Operations & Portfolio Management (DO&PM) domain. In this role, a typical day might include the following: Lead & coach the Product Leads and Product Analysts within GDIT Delivery & Operations assigned to the domain, ensuring delivery on team commitments, collaboration across members, and definitions of processes, tools and competencies needed to further build the domain capabilities. Oversee all operational support for products and domain providing line leadership and guidance to individual product owners, while thinking across product lines. Work with senior leadership & across Delivery & Operations domain teams to ensure alignment on deliverables, objectives, processes & standards. Ensure alignment with product model processes and standards while customizing to meet domain-specific needs, as applicable. Monitor team’s overall delivery and assess team’s performance. Build relationships with key leaders, partners and stakeholders to clarify and negotiate when needed on demands and solutions. Develop and present new ideas, concepts, approaches and solutions Take ownership of product including end-to-end support, performance, and commitment to continuous improvement. This Job Might Be For You If You Have: Deep knowledge of Development Operations & Portfolio Management business processes, including but not limited to Drug Development Program and Portfolio Management; Resource Management; Clinical Trial Feasibility, Planning, Execution, and Closeout; Clinical Monitoring; Study Start-up; Site Management; and Clinical Drug Supply Management. Experience managing technology teams and driving business value in the Clinical Operations space with specific technologies like Veeva Clinical Vault (CTMS, TMF, SSU, etc.), CluePoints, Planisware, etc., a plus. Proven ability to manage competing priorities across a multitude of stakeholders and to direct teams to deliver value-oriented, prioritized solutions. Excellent communication skills and the ability to indirectly influence key partners and stakeholders with clear, concise, and well-formed message tailored to the audience To be considered for this role, you must have: Bachelor’s degree in a related field 15+ years of experience in Oracle ERP applications testing, quality assurance, or release management Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $183,100.00 - $305,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Sales Operations
Agile/Scrum Methodologies
Direct Apply
Posted 23 days ago
RP

Senior Manager Clinical Study Lead (Oncology)

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Cambridge, England, United Kingdom, Warren, MichiganFull-time
View Job
Compensation$90K - 130K a year

Manage complex projects and lead teams to deliver operational and technological solutions. | Bachelor's degree and extensive leadership experience, but no clinical trial or regulatory compliance experience. | The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Leadership
Project Management
Process Improvement
Direct Apply
Posted 24 days ago
RP

Manager Clinical Data Operations

Regeneron PharmaceuticalsWarren, MichiganFull-time
View Job
Compensation$80K - 120K a year

Lead and manage projects involving digital transformations, sales operations, and system implementations to improve organizational efficiency. | Experience in project management, sales leadership, and system implementation with strong skills in Salesforce and KPI development but no clinical data or visualization expertise. | SUMMARY The Manager, Clinical Data Operations will lead the development and delivery of clinical data visualization solutions to support high-quality clinical trial execution across clinical development programs. This role is responsible for leveraging the data from the Scientific Data Lake to create a unified ecosystem of participant-level data visualizations, data quality oversight, external data reconciliation insights, operational and site performance intelligence, audit trail insights, database-lock readiness indicators, and other KPI metrics. The incumbent will be responsible for enabling a data-driven and actionable insights framework aimed to enhance business capabilities, improve operational efficiencies and oversight, and accelerate decision-making. The ideal candidate will work closely with cross-functional teams to ensure that the clinical data visualization solutions meet the business needs, align with the departmental goals, and adhere to regulatory and compliance standards. JOB DUTIES Lead the design and development of clinical data visualization solutions that support participant-level tracking, data quality oversight, operational and site performance insights, audit trail insights, database-lock indicators, and other KPI metrics. Ensure that the analytical and visualization solutions provide actionable insights to improve clinical data oversight, facilitate efficient data cleaning and review, monitor operational performance, enable improved visibility and decision-making. Engage with cross-functional stakeholders to understand the data needs, define requirements, develop specifications, design and deliver solutions that enhance transparency, efficiency, and operational performance. Facilitate alignment between technical teams and business partners to ensure requirements are transformed into scalable, long-term data visualization capabilities. Manage the lifecycle of analytical and data visualization solutions from proof-of-concept and requirements gathering through testing, deployment, and continuous improvement. Source and integrate data from the Scientific Data Lake, ensuring data quality, consistency, and alignment with business requirements. Collaborate with the Scientific Data Lake Operations team to optimize data pipelines, metadata management, and ensure seamless access to required datasets. Develop and maintain robust clinical data visualization solutions to provide real-time visibility into study progress and performance and fulfill critical study milestones and priorities to accelerate clinical study execution and improve oversight. Deliver operational insights to identify risks, bottlenecks, and opportunities to drive process improvements and optimization initiatives. Ensure all data insight and visualization workflows comply with GCP, ICH, GDPR, SOPs, and regulatory expectations. Drive adherence to data governance principles to safeguard and maintain the security, privacy, and integrity of clinical data. Stay updated on emerging technologies and tools in data visualization and analytics to enhance business capabilities. Drive the adoption of innovative solutions to improve the efficiency and scalability of clinical data visualization solutions. Provide leadership and guidance to junior team members engaged in the development of clinical data visualization solutions. Foster a culture of collaboration, innovation, and continuous improvement within the Clinical Data Operations team. JOB REQUIREMENTS Bachelor’s or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field. 7+ years of experience in clinical data, data visualization, or related disciplines, with a strong background in creating interactive reporting solutions, KPIs, and metrics to support clinical trial oversight. Proficiency in data visualization tools such as Tableau, Power BI, or Spotfire. Experience with optimization and maintenance of data pipelines, workflow automation, data quality standards, and strong understanding of data lifecycle management in a regulated environment. Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (e.g., GCP, GDPR, HIPAA). Experience with data lakes, data pipelines, data integration, automation, and analytics in a clinical research environment. Excellent communication and stakeholder management skills. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $114,800.00 - $187,400.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Sales Operations
Salesforce.com
Agile/Scrum
KPI Development
Direct Apply
Posted 24 days ago
RP

Senior Manager Clinical Study Lead (Hematology)

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Cambridge, England, United Kingdom, Uxbridge, England, United Kingdom, Warren, Michigan, Armonk, New YorkFull-time
View Job
Compensation$151K - 246K a year

Manage and deliver complex projects and sales operations with leadership and strategic planning. | Bachelor's degree with senior leadership and project management experience, but no clinical trial or healthcare background. | The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $150,500.00 - $245,500.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Sales Operations
Digital Transformation
Agile/Scrum Methodologies
Vendor Management
Direct Apply
Posted 25 days ago
RP

Associate Director, Regulatory Medical Writing

Regeneron PharmaceuticalsAnywhereFull-time
View Job
Compensation$80K - 120K a year

Lead medical writing deliverables, manage writers, develop document strategy, and lead regulatory submissions. | 8+ years medical writing experience, advanced degree preferred, expert knowledge of clinical research regulations and writing. | As an Associate Director, Medical Writing, you will represent Medical Writing and provide leadership in one or more compound areas, oversees junior writers, and may assist in leading regulatory submissions. We work closely with senior Medical Writing management to help produce and ensure adherence to department guidelines, templates, standard timelines, and SOPs that follow regulatory guidelines. Responsibility will also include managing and developing staff; this may include performance management and training. Additionally, you will independently write all in-scope clinical documentation in their compound areas. This position can be either fully remote or can be on-site at our Sleepy Hollow, NY or Warren, NJ offices. A typical day may include the following: • Leads all MW deliverable work for assigned compounds/indications • Manages work of both internal and outsourced Medical Writers • Works with clinical team to develop document strategy and write in-scope deliverables as needed • Develop and articulates document strategy and timelines • Identifies appropriate decision makers, focuses on results/actions. • Leads regulatory submissions/submission document writing • Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development • Participates in new initiatives within MW and throughout Global Development • Manages processes and organize priorities; solves problems; fosters collaboration to resolve conflict • Leads, challenges, and develops MW team • Manages and develops staff; this may include performance management, recruiting, coaching, and training • Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area • Remains compliant with internal training This may be for you if you: • Present as a leader; is looked to for actions and decisions • Can demonstrate success in managing multiple projects. • Want to have an impact on patient lives. • Are interested in mentoring or leading people To be considered a bachelor’s degree is required with an advanced degree being preferred. A minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement). Expert knowledge of the clinical research process and regulations/guidelines and regulatory writing is required. Expert clinical document reading, writing, and editing experience. Proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems. Thorough understanding of ICH GCP guidelines. Any experience managing medical writers is helpful. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $176,100.00 - $287,300.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Medical Writing
Regulatory Submissions
Staff Management
Direct Apply
Posted 25 days ago
RP

Director, Privacy Counsel

Regeneron PharmaceuticalsAnywhereFull-time
View Job
Compensation$202K - 337K a year

Providing legal advice on privacy issues, assessing privacy risks, developing policies, and collaborating on privacy initiatives. | JD license in New York, 5-7 years legal experience with at least 3 in privacy, industry-specific experience in biotech/pharma preferred. | As a key member of the Privacy Office in Regeneron’s Law Department, this role will enable our rapidly growing and globally expanding business to develop and execute on innovative data-driven strategies in accordance with data privacy and related laws. The successful candidate will effectively partner with Law Department colleagues and other functions at Regeneron, provide expert and pragmatic counseling to senior leaders, and provide leadership and subject matter expertise to drive the continued improvement and implementation of Regeneron’s data privacy program. • *_This role can be based at Regeneron's offices in Cambridge, MA or Sleepy Hollow, NY (4 days a week onsite) - it is not open to hybrid or fully remote assignments._** • *A typical day might include:** + Providing advice and counseling on a wide range of privacy and related issues such as advising on sensitive data, digital advertising, and use of emerging technologies/AI. + Strategically assess potential privacy risks on new projects, including risk-mitigation counseling and advising on appropriate controls. + Monitoring emerging regulations and supporting the operationalization of compliance with evolving laws. + Upkeep and development of internal policies, procedures, and guidance documents; educating business clients through training and awareness programs; Improving and counseling on privacy program operations. + Working with Regeneron’s Privacy Steward Council to drive initiatives that enhance data privacy across the organization. + Collaborating with our Government Affairs division on opportunities to influence legislation. + Assisting contracting teams in drafting, maintaining, and negotiating data processing agreements. + Participating in industry group meetings to stay updated on best practices and emerging trends. • *This role might be for you if you have:** + Strong knowledge of local and global privacy laws and their application to the pharmaceutical/biotechnology industry. + Deep understanding of privacy risks associated with ad tech and emerging technologies. + Excellent relationship building skills. + Demonstrated ability to work collaboratively and with all levels of the workforce. + Exceptional oral, written, and presentation communication skills, with the ability to effectively communicate and translate legal analysis to business counsel to a varied audience. + High level of business acumen, influencing skills and ability to drive change. + You are willing to take on a leadership role in an important, dynamic and challenging field. • *To be considered for this role, you must have a JD and be licensed to practice law in New York (or eligible for licensure as a registered in-house counsel). 5-7 years of legal experience at a law firm and/or in-house, and at least 3 years of experience in privacy. Ad Tech, Biotechnology, pharmaceutical or related life science experience is strongly preferred.** Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. • *Salary Range (annually)** $202,000.00 - $336,600.00 As a key member of the Privacy Office in Regeneron’s Law Department, this role will enable our rapidly growing and globally expanding business to develop and execute on innovative data-driven strategies in accordance with data privacy and related laws. The successful candidate will effectively partner with Law Department colleagues and other functions at Regeneron, provide expert and pragmatic counseling to senior leaders, and provide leadership and subject matter expertise to drive the continued improvement and implementation of Regeneron’s data privacy program. • *_This role can be based at Regeneron's offices in Cambridge, MA or Sleepy Hollow, NY (4 days a week onsite) - it is not open to hybrid or fully remote assignments._** • *A typical day might include:** + Providing advice and counseling on a wide range of privacy and related issues such as advising on sensitive data, digital advertising, and use of emerging technologies/AI. + Strategically assess potential privacy risks on new projects, including risk-mitigation counseling and advising on appropriate controls. + Monitoring emerging regulations and supporting the operationalization of compliance with evolving laws. + Upkeep and development of internal policies, procedures, and guidance documents; educating business clients through training and awareness programs; Improving and counseling on privacy program operations. + Working with Regeneron’s Privacy Steward Council to drive initiatives that enhance data privacy across the organization. + Collaborating with our Government Affairs division on opportunities to influence legislation. + Assisting contracting teams in drafting, maintaining, and negotiating data processing agreements. + Participating in industry group meetings to stay updated on best practices and emerging trends. • *This role might be for you if you have:** + Strong knowledge of local and global privacy laws and their application to the pharmaceutical/biotechnology industry. + Deep understanding of privacy risks associated with ad tech and emerging technologies. + Excellent relationship building skills. + Demonstrated ability to work collaboratively and with all levels of the workforce. + Exceptional oral, written, and presentation communication skills, with the ability to effectively communicate and translate legal analysis to business counsel to a varied audience. + High level of business acumen, influencing skills and ability to drive change. + You are willing to take on a leadership role in an important, dynamic and challenging field. • *To be considered for this role, you must have a JD and be licensed to practice law in New York (or eligible for licensure as a registered in-house counsel). 5-7 years of legal experience at a law firm and/or in-house, and at least 3 years of experience in privacy. Ad Tech, Biotechnology, pharmaceutical or related life science experience is strongly preferred.** Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. • *Salary Range (annually)** $202,000.00 - $336,600.00

Data Privacy & Compliance Programs
Legal Counseling & Strategy
Contract Negotiation
Verified Source
Posted 30 days ago
RP

Director Program Operations Leader, Oncology

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Cambridge, England, United Kingdom, Uxbridge, England, United Kingdom, Warren, Michigan, Armonk, New YorkFull-time
View Job
Compensation$205K - 342K a year

Oversee clinical trial programs, manage budgets, timelines, and teams, and develop operational strategies for clinical research. | Extensive experience in clinical operations within the pharmaceutical or biotech industry, including managing clinical trials, budgets, and vendor relationships, with a strong understanding of regulatory compliance. | The Director Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. Director Program Operations Leader - Oncology (For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.) In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Act as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drives the strategy and oversight for vendor selection and management within a clinical program(s) Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $205,000.00 - $341,600.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Operational Strategy
Vendor Management
Direct Apply
Posted about 1 month ago
RP

Senior Manager, Clinical Outcomes Assessment

Regeneron PharmaceuticalsSleepy Hollow, Illinois, Warren, Michigan, Armonk, New YorkFull-time
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Compensation$134K - 219K a year

Oversee and implement digital health technologies in clinical research studies, manage vendor performance, and ensure compliance with regulatory standards. | Minimum 8+ years of industry experience, knowledge of digital tools within clinical trial systems, and familiarity with ICH/GCP guidelines. | As a Senior Manager, Digital Health Technologies (DHT) you will be accountable for implementation of digital tools and technologies (e.g. electronic COA (eCOA), eConsent, wearables, sensors, spirometry, ECG) in individual clinical research studies from study design to close out. We support digital tool and technology project timelines, translation, specifications, implementing UAT, and ensuring collection of such data in accordance with our SOPs and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). This position is on-site either in Sleepy Hollow, NY or Warren, NJ locations. If eligible, we can offer relocation assistance. We cannot offer a remote work option. A typical day may include the following: • Responsible for reviewing and approving various project related digital tool and technology study documentation during the course of the project lifecycle. • Applies patient technology expertise on day-to-day activities when issues are brought up. • Communicates with internal and external partners and raises risks. • Provides input into protocol development as it relates to digital tools and technologies. • Support the integration of all supported digital tools and technologies into existing systems and workflows to minimize disruption and improve efficiency. • Oversee or supports license acquisitions and purchasing of digital tools and technologies. • Responsible for the selection of the digital tool and technology vendor selection, in collaboration with study team. • Oversee vendor performance at the clinical trial level, performing root cause analysis and identifying corrective actions, and serving as point of escalation for issues. • Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables • Provides support for problem resolution between vendors and Regeneron study team. • Monitor financial components related to digital tools and technologies for each study. • Collaborate with study team members on medical monitoring plan. • Collaborate with data management on all digital tool data specifications, standards, and transfers. • Provides training and mentor new staff. • Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations. • Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment. • Communicates clinical innovations in eSource modalities to stakeholders and broader organization. • Develop trial strategy for implementation of innovative clinical trial technologies and radical innovations. • Provide consultation on all digital tool modality benefits, risks, costs and process. • Facilitates and contributes to study level lessons learned. • Recommends and participates in cross-functional and departmental process improvement initiatives. • May require up to 25% travel. This may be for you if you: • Want to have an impact on patient lives. • Have a data driven approach to planning, executing, and problem solving • Can demonstrate effective project management skills, cross-functional team leadership and organizational skills. To be considered you are to have a bachelor’s degree and minimum of 8+ years’ relevant industry experience. Demonstrate knowledge of digital tools and technologies within the eCOA systems development processes. Ability to understand and implement our strategic direction and guidance for respective clinical studies. Technical proficiency in trial management systems and Microsoft Project Server. Knowledge of ICH/GCP and regulatory guidelines/directives Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $134,400.00 - $219,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Digital Transformation
System Implementation
Direct Apply
Posted about 1 month ago
RP

Senior Director Commercial Planning & Strategy, Global Rare Disease & Cardio-metabolic

Regeneron PharmaceuticalsAnywhereFull-time
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Compensation$216K - 360K a year

Lead global strategic planning and execution for rare disease and cardiometabolic products, aligning cross-regional teams and managing lifecycle initiatives. | Requires 12+ years in life science strategy or biopharmaceuticals, with 4-6+ years in rare disease, and experience in brand marketing, business development, or commercial operations. | We are seeking a dynamic and strategic leader to join our team as the Senior Director Commercial Planning & Strategy within the Global Rare Disease & Cardio-metabolic Commercial Business Unit (CBU). This pivotal role will build the future of our portfolio, driving strategic planning and execution across global markets. Reporting to the Executive Director, Global Strategic Customer Engagement, you will collaborate with leadership teams to align commercial objectives with our broader organizational goals. If you are passionate about innovation, thrive in complex environments, and are eager to make a significant impact in rare and ultra-rare diseases, this role is for you. A Typical Day: Lead cross-functional and cross-regional integration efforts to ensure alignment and operational efficiency across the Rare Disease & Cardiometabolic CBU. Develop and oversee long-term strategies aligned with product lifecycle stages, ensuring integration with marketing, R&D, and regulatory teams. Manage distributor relationships, ensuring adherence to service levels and effective delivery to international markets. Monitor and analyze key industry trends, category data, and brand performance metrics to inform strategic decisions. Drive lifecycle management initiatives and influence the strategic direction for commercialized products and pipeline assets. This Role May Be For You If: You have a proven ability to manage multiple projects and meet tight deadlines while maintaining high quality. You excel at building trust, gaining alignment, and navigating ambiguity in cross-functional teams. You thrive in a collaborative environment and have strong leadership skills to guide teams toward shared goals. You are a strategic thinker who can analyze complex trends and provide actionable insights. You have a passion for rare and ultra-rare diseases and are eager to make a difference in patients’ lives. To Be Considered: You must have at least 12+ years of progressive experience in life science strategy or business management consulting, with 4–6+ years in the pharmaceutical/biopharmaceutical market, including rare disease experience. A strong background in brand marketing, business development, or commercial operations is essential. Advanced degrees (e.g., PhD, MD, MBA) and experience in ultra-rare disease, franchise marketing, and product launches are strongly preferred. This role has international travel approximately 10–15% of the time. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $216,100.00 - $360,200.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Strategic Planning
Cross-functional Leadership
Industry Trend Analysis
Direct Apply
Posted about 1 month ago
RP

Director Program Operations Leader - Oncology-Hematology

Regeneron PharmaceuticalsWarren, MIFull-time
View Job
Compensation$0K - 0K a year

Oversee clinical trial programs, manage budgets, and lead cross-functional teams to ensure successful clinical research execution. | Requires extensive experience in clinical operations, regulatory compliance, and leadership in pharmaceutical or biotech settings, with a minimum of 12 years in-house sponsor-side experience. | The Director Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. Director Program Operations Leader - Oncology-Hematology (For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.) In a typical day, you will: • Be responsible for the overall success of the clinical study team(s) within a program(s) • Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested • Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development • Oversee clinical study timelines within a clinical program(s) • Provide input and operational insight into Clinical Study Concepts (CSC) • Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol • Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM • Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate • Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). • Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation • Act as point of contact for clinical program and study level escalation • Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress • Provide proactive creation and implementation of risk mitigation strategies • Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges • Drives the strategy and oversight for vendor selection and management within a clinical program(s) • Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts • May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. For US Locations, this position is on-site 4 days per week and 1 day from home. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Project Management
Stakeholder Management
Process Improvement
Verified Source
Posted about 1 month ago
RP

Director Program Operations Leader - Oncology-Hematology

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Uxbridge, England, United Kingdom, Boston, Massachusetts, Warren, Michigan, Armonk, New YorkFull-time
View Job
Compensation$200K - 250K a year

Oversee clinical program operations, manage budgets, and lead cross-functional teams to ensure successful clinical trial execution. | Extensive experience in clinical operations within the pharmaceutical or biotech industry, including managing clinical trials, budgets, and vendor relationships, with a relevant educational background. | The Director Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. Director Program Operations Leader - Oncology-Hematology (For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.) In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Act as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drives the strategy and oversight for vendor selection and management within a clinical program(s) Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. For US Locations, this position is on-site 4 days per week and 1 day from home. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Stakeholder Management
Process Improvement
Direct Apply
Posted about 1 month ago
RP

Director, Program Operations Leader - Ophthalmology/Renal

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Cambridge, England, United Kingdom, Uxbridge, England, United Kingdom, Warren, Michigan, Armonk, New YorkFull-time
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Compensation$205K - 342K a year

Oversee and lead clinical trial programs, manage budgets, timelines, and vendor relationships, and ensure compliance with regulations. | Extensive experience in clinical operations, program management, and leadership in pharmaceutical or biotech settings, with a focus on clinical trial management. | For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Act as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drives the strategy and oversight for vendor selection and management within a clinical program(s) Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $205,000.00 - $341,600.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Stakeholder Management
Process Improvement
Direct Apply
Posted about 1 month ago
RP

Senior Manager Clinical Imaging Operations

Regeneron PharmaceuticalsTarrytown, Georgia, Warren, MichiganFull-time
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Compensation$151K - 246K a year

Oversee and manage clinical imaging operations across multiple trials, ensuring compliance, quality, and collaboration with vendors and study teams. | Requires 8+ years of clinical trial imaging experience, certification as a Registered Technologist, and experience in a pharmaceutical setting. | As a Clinical Imaging Operations Lead, you will have a leading role in the design and execution of key strategic and operational aspects of complex early and late phase clinical trials across multiple therapeutic areas, where imaging is a primary or key endpoint. You will collaborate with Clinical Imaging Science Leads and be fully integrated within clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with all study specific procedures. You should expect to work closely with our imaging vendor partners, the clinical operations function, the data management function, external clinical research organizations (CROs), and clinical sites to ensure the successful completion of startup activities, ongoing execution, and close-out of clinical studies. A day in the life may look like: Portfolio Oversight: Responsible for the execution, functional reporting, and imaging operational oversight of specific portfolios/assets through direct study management or indirect guidance of other team members working on the portfolio. Expected to develop an in-depth knowledge aligned to the portfolio and close relationships with cross-functional colleagues in similar supporting roles. Imaging Startup and Project Management Support: Collaborate with clinical operations study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials. Assist with imaging vendor selection, request for proposals, management, and performance tracking. Study Documentation and Compliance: Author, review, and/or manage essential study documents such as Imaging Manuals, Independent Review Charters, Communication plans, data transmittal forms, Standard Operating Procedures, and Work Instructions. Ensure all documentation is audit-ready and filed appropriately in the Trial Master File (TMF). Site Management and Training: Provide technical support and training to clinical site personnel, which may include conducting site initiation visits or Teleconferences. Review and approve training materials for imaging facilities and/or clinical site personnel. Process & Technology Improvement: Participate in process and technology improvement initiatives and ensure strict compliance with all procedures and regulations. This may be the right role for you if you have: A well-developed knowledge of clinical imaging across multiple indications alongside an in-depth knowledge of multiple imaging vendors. Excellent communication and organizational skills alongside strong capabilities to provide succinct and impactful updates that demonstrate a developed understanding of the impact of imaging. People management experience is highly preferred as the role will be expected to mentor other team members effectively and may have direct reports. In Order to be considered qualified for this role you must have: : · BA/BS with 8+ years of clinical trial imaging experience · Certification as a Registered Technologist (R.T.) with experience in modalities like CT, MRI, or Nuclear Medicine is highly preferred · At least 3 years of imaging operational clinical trial experience in a pharmaceutical (sponsor) setting Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $150,500.00 - $245,500.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Clinical Imaging
Project Management
Vendor Management
Direct Apply
Posted about 1 month ago
RP

Senior Director, Global Patient Safety - General Medicine

Regeneron PharmaceuticalsTarrytown, Georgia, Warren, MichiganFull-time
View Job
Compensation$242K - 403K a year

Manage and lead safety activities for pharmaceutical compounds, including safety surveillance, signal management, and regulatory communication. | Requires 15+ years in pharmacovigilance or clinical development, with experience in specialty therapies and regulatory guidelines, which your profile does not demonstrate. | Regeneron's Patient Safety Organization is looking for a Senior Director to join our organization! In this role, a typical day might include: Reporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director GPS Lead, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA). This position is directly responsible for all aspects of GPS activities for assigned compounds and products in support of safety surveillance, signal management, communication of the safety profile as appropriate for the stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) The GPS Lead is the GPS representative on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively with stakeholders to deliver the safety profile and the safety strategy. Assigned compounds will include a variety obesity/metabolism products in various stages of development. This position requires the ability to work with and influence colleagues in a matrix environment within and external to GPS including senior management. This role might be for you if can: Leads cross-functional Safety Monitoring Team (SMT) activities Represent GPS for assigned compounds on cross-functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT) and other teams with members external to Regeneron (alliance partners, CROs) Serves as delegate as needed for GPS Therapeutic Area Head, General Medicine Proactively identify and develop safety strategies and planning for non-compound specific GPS activities (mechanism of action etc.) Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds Actively participate in the development and maintenance of relevant SOPs, working practices and guides Actively participates in continuous improvement activities within both the TA and the GPS organization, including cultivating cross functional relationships and mentoring junior safety scientists To be considered for this opportunity, you must have the following: 5+ years of total relevant experience in PV and/or relevant medical field with PharmD / PhD / MD degree 15+ years of total relevant experience in PV and/or relevant medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content) Demonstrated experience in specialty TAs incorporating advanced therapies, such as gene therapy into pharmacovigilance practices Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required. Function as a subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest. Thorough understanding of drug development and context as applicable to safety surveillance activities A proven ability to lead and develop a diverse team of safety professionals in a constructive, goal-oriented environment. An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. Ability to utilize GPS safety database for purposes of medical case review and simple queries. #MDJobsRA #MDJobs #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $242,000.00 - $403,300.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Project Management
Digital Transformation
System Implementation
Direct Apply
Posted about 1 month ago
RP

Senior Manager, Global Patient Safety - General Medicine

Regeneron PharmaceuticalsDublin, Leinster, Ireland, Uxbridge, England, United Kingdom, Tarrytown, Georgia, Warren, MichiganFull-time
View Job
Compensation$151K - 246K a year

Manage safety data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment in clinical development and post-marketing phases. | Requires a Master's, PhD, or PharmD with 7+ years of risk management experience in the pharmaceutical/biotech industry or health authority. | The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. In this role, a typical day might include: Complete signal detection activities in line with approved safety surveillance plan Perform signal evaluation for any identified signals and author the safety evaluation reports Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds Participate in other risk management activities as appropriate for assigned compounds We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents This role might be for you if can/have the: Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments Ability to work with a safety system database for purposes of medical case review and simple queries Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize Ability to effectively communicate (verbal and written) safety findings To be considered for this opportunity, you must have the following: Minimum a Master's, PhD, or PharmD Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $150,500.00 - $245,500.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Regulatory Safety Compliance
Pharmacovigilance
Risk Management
Direct Apply
Posted about 1 month ago

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