4 open positions available
Lead clinical trial feasibility, operational planning, and vendor management to optimize global study execution. | Minimum 8 years in pharma/biotech or CRO, with experience in clinical development, data-driven strategy, and process change management. | The Senior Manager, Global Trial Optimization will lead program or study level activities advising on our clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. You will develop and maintain relationships with our external experts facilitating a wide source of country and disease area intelligence used in study design and operational planning. A typical day may include the following: • Lead study level feasibility processes to generate high quality and timely data to inform study design, efficient geographical placement and operational planning. • Partner with teams during CRO led feasibility activities supporting validation of study and country level enrollment rates and study start up timelines to advise budget and baseline setting. • Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management. • Partner with Data and Analytics function to review and identify appropriate central data sources. • Articulate the data story to teams based on country level feasibility and centrally derived data to support data driven decisions to improve protocol design • Project management of study level country landscape assessment activities and the collection of targeted feasibility information for early assessment of operational feasibility for conducting clinical trials. • Lead study level engagements to acquire, analyze and deliver high quality targeted information from external partners. • Prove input into continuous improvement activities to ensure consistency of process execution. • In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors. • Develop and implement patient recruitment and retention tactics aligned with defined study strategy. • Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution • May require up to 20% travel To be considered a Bachelors degree in a related field with a minimum of 8 years of relevant industry experience within pharma/biotech, a CRO or consulting is required. Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval. Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences. Additional requirements include: • Experience in using data to inform clinical strategy development • Ability to understand sophisticated business questions and develop effective solutions • Experience in process development, implementation and change management activities • Line management experience 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) $134,400.00 - $219,200.00
Leading sales teams in the dermatology/biopharmaceutical sector, developing talent, and managing performance within a complex regulatory environment. | Minimum 7 years of pharmaceutical/biopharmaceutical sales experience with 3 years in sales leadership, preferably in dermatology, with a focus on managing teams and understanding payer environments. | Geography: Texas: Houston, San Antonio, Austin The District Manager (DM), Dermatology will report to the Regional Director, Dermatology and be responsible for hiring, leading, developing and retaining the Dermatology Medical Specialists in their assigned district. A Typical Might Look Like This: The DM is responsible for ensuring strong and consistent sales performance that exceeds forecast and expectations relating to product goals and driving accountability for all results throughout the Dermatology District assigned. The DM will work closely with their Alliance partner counterpart(s) to insure full cooperation and transparency. The DM will work closely to ensure appropriate development and retention of key personnel within the district to continue to facilitate growth in the commercial organization. The DM will accomplish this in a compliant manner with a high degree of integrity strictly following all Regeneron policies and in compliance with all policies and procedures governing the promotion of pharmaceutical and biologic products in the US. This Position Might Be for You If: • Successful leadership record of hiring, coaching, developing, promoting, and retaining top talent within span of control and ability to effectively manage performance of the team. • Proven success and positive track record of performance with a high degree of integrity as a District Sales Manager in complex markets within complex systems required. • Strong understanding of Payer environment, reimbursement and challenges within National, Regional and local payer market including; government programs, managed health care and evolving health care systems. • Proven ability and success in developing physician/customer clinical experts in a Regional scope required. • Ability to partner and collaborate with other internal field teams and alliance partners. To be considered for this opportunity you will have the following: Bachelor’s degree required, Master’s degree or other advanced education/certifications a plus (Focused degree in science or clinical experience is a plus). Minimum of 7 years of pharmaceutical/biopharmaceutical experience with 3 years of sales leadership/management in office-based, sub-cutaneous self-injectable biologic markets required. Experience in the Dermatology market preferred. Ability to travel extensively with local and regional influence. To be considered for this role, candidates must reside within the listed territory. #derm 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) $175,300.00 - $218,900.00
Manage translation workflows, liaise with vendors, and ensure timely, compliant document translations across global operations. | 7+ years of relevant experience, translation management background, project management skills, and proficiency in Microsoft Office. | The Manager, Translation Services manages the workflow of various documents needing processing, including those that require translations for local country locations. This role would Lead and optimize end‑to‑end translation workflows, ensuring timely and compliant processing of documents requiring translation across global country operations. This role would serve as the primary liaison between central functions and external translation partners and submit documents for translations with the translation vendor. In the event of a Merger or Acquisition, works with the team to develop and implement translation strategies ensuring records are translated appropriately based on regulatory, operational, and business‑use requirements. Act as the organization's subject matter expert for translation needs during audits and inspections. Leads translation efforts for audits or inspections such as record translations or contracting of interpreters. Oversee vendor, tracks progress and reports out status for document requests, escalating when necessary. Support strategic and operational special projects, applying translation expertise to enhance workflows, systems, and organizational readiness. Co-chair Translations Alliance (SME Group). May have management responsibilities depending on resourcing needs. A typical day in this role looks like: • Works with functional areas to determine which documents require translations • Manages the submission, workflow and receipt of documents and other materials with the translation service providers • Collaborates with functional areas to ensure translation requirements are properly documented and provided to service providers and collaborators, as needed. • Maintains, manages and tracks metrics that support the performance of the translation process and its status across all functions in scope. Escalates to management as necessary • Collect and report to management and the service provider all translation quality issues and track to resolution while keeping the requester informed. • Ensures that translated documents are provided to requesters timely and placed in the appropriate repository. • Co-Chair of Translations Alliance. • Effectively communicates and drives document translation risks and issues to the teams • Attends functional meetings to capture and ensure all document translation related tasks are clearly identified and appropriate timelines are defined. • Manages and corresponds with translation vendor to ensure seamless workflow • Work with translation vendor to address any system technical issues through resolution as necessary. • Trains functional areas on good translatability requirements. • Special projects as assigned. This role may be for you if you have: • Translation management background • Project management experience to create and manage plans • Demonstrated ability to prioritize and manage multiple projects simultaneously • Demonstrated ability to work effectively with many different types of personalities at all levels of the organization and with vendor partners • Demonstrated interpersonal, collaboration and stakeholder management skills • Excellent communication skills (written/verbal) • Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure • Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking • Highly proactive, flexible, curious and resilient • Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint In order to be considered qualified for this role, a minimum of a Bachelors degree or equivalent and 7+ years of relevant expereince is required 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
Lead and oversee global execution of complex clinical trials including study design, budget and timeline management, vendor oversight, regulatory compliance, and team leadership. | Minimum Bachelor's degree with 8+ years clinical trial experience, advanced project management and leadership skills, knowledge of ICH/GCP and regulatory guidelines, and experience with clinical trial systems. | 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. (Armonk, NY / Warren, NJ / Cambridge, MA / Dublin, Ireland / Uxbridge, London) 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. A background in clinical trials within cell therapy is highly 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) $148,300.00 - $241,900.00
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