MO

Moderna

4 open positions available

4 locations
1 employment type
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Full-time

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MO

Senior Director, Nonclinical Safety Evaluation

ModernaCambridge, MassachusettsFull-time
View Job
Compensation$197K - 353K a year

Provide strategic and operational leadership for nonclinical safety evaluation, including toxicology and pathology, supporting regulatory submissions and product development. | PhD with 11+ years in nonclinical safety assessment, experience in toxicology, regulatory interactions, and managing teams in pharma/biotech. | The Role At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual’s contribution is vital. We are seeking a seasoned scientific leader to serve in a senior leadership role within Nonclinical Safety Evaluation, providing strategic and operational leadership for Toxicology and Pathology. This role will serve on a leadership team with other nonclinical leaders and will partner closely with other cross-functional stakeholders to ensure scientifically rigorous, acceptable, and compliant nonclinical safety strategies and data packages to support regulatory submissions. This role will have specific emphasis and accountability for products in Moderna’s emerging and/or established Cancer Antigen Therapy and Infectious Disease portfolios, with additional responsibilities in other therapeutic areas as needed based on evolving business needs. Here’s What You’ll Do In alignment with the corporate mindsets, provide direct and matrix management of a high performing team of Toxicologists and Pathologists across a range of job levels, cultivating a culture of innovation, collaboration, excellence, and continuous learning. Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation of products within the assigned therapeutic area(s) from discovery to post-marketing. Apply in-depth knowledge of how nonclinical safety disciplines (including but not limited to general toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, and carcinogenicity) integrate with other areas across the business. Evaluate nonclinical safety challenges in a complex or fast-changing environment and direct the development of new or innovative solutions with in-depth analysis and interpretive thinking. Provide strategic oversight on and coach/guide team members on the development of scientifically-sound nonclinical safety strategies to provide expert support to discovery and development projects. Accountable for the design, execution, critical analysis, and reporting of GLP/non-GLP nonclinical safety in vitro and/or in vivo studies conducted in multiple species under the nonclinical safety assessment umbrella for the assigned therapeutic area(s) via collaborative partnerships with study monitors and program team representatives (e.g., DMPK, bioanalytical, operations, etc.). May be accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification. Serve as a key scientific contributor in regulatory agency interactions, internal governance and/or leadership meetings when nonclinical data package conclusions and impact of GLP/non-GLP study results on program and clinical/regulatory strategy are presented. Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents (INDs, CTAs, BLAs and MAAs) and health authority interaction documents (e.g., briefing documents, regulatory query responses), ensuring effective integration of toxicology results with DMPK and pharmacology for the assigned therapeutic area(s). Ensure alignment of toxicology narratives with clinical development plans and regulatory strategies. Oversee the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal/external partners and/or scientific groups in a concise and meaningful way. Maintain extensive scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large. In addition to providing direct and matrix management, the incumbent will also serve as an independent contributor for a select number of discovery and/or pipeline programs as a Toxicology Lead. Here’s What You’ll Need (Basic Qualifications) PhD & 11 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical development. Strong consideration will be given to those with experience in nucleic acid-based and nanoparticle modalities, immune-modulating therapeutics, oncology, and/or infectious disease vaccine drug development. Experience serving in and/or managing colleagues serving in the capacity of a Toxicology representative role on drug development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and GLP/non-GLP studies to support clinical development and regulatory submissions. Experience in mentoring, coaching, and/or managing others. Experience applying regulatory guideline knowledge in the conduct of nonclinical safety studies to support regulatory filings. Direct experience in writing, reviewing, and critiquing nonclinical sections of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs, briefing documents, regulatory query responses) and interacting with regulatory agencies. Passion for people management, team building, and creative solution seeking for organizational development. Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders. Attention to detail and quality, and ability to deliver work on time. Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $196,700.00 - $353,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Regulatory Strategy
Quality Assurance (GxP)
Regulatory Compliance
Direct Apply
Posted 15 days ago
Moderna

Senior Director, Regional Accounts, West

ModernaAnywhereFull-time
View Job
Compensation$197K - 353K a year

Lead and develop a team of Regional Account Managers to drive growth and access to Moderna's respiratory vaccines across a specified U.S. region. | Minimum 10 years in pharma/biotech commercial roles with 5+ years managing field teams, with experience in vaccines preferred. | The Role As part of our continued growth and expansion in respiratory vaccines, Moderna is scaling its U.S. commercial organization. We are seeking a strategic and experienced leader to drive regional customer engagement, field execution, and team development within our Regional Accounts organization. This role is responsible for leading a team of Regional Account Managers (RAMs) across a defined U.S. region. Together, the team will build deep, strategic relationships across a range of high-impact customer segments—including integrated delivery networks (IDNs), state and federal public health agencies (e.g., CDC, BARDA, VFC), Federally Qualified Health Centers (FQHCs), GPOs, and large physician/provider networks. You will own the design and execution of the regional go-to-market strategy, ensuring seamless alignment between field execution and national brand objectives. This is a remote role, requiring regional presence and regular travel. Here’s What You’ll Do • Develop strategic account plans that will enhance customer relationships, achieve sales targets, facilitate retention and growth within key customers (IDNs, Health Systems, FQHCs, Awardees, Physician Groups, Contracting Entities, etc.) to support and oversee successful communication and negotiation • Act as the primary point of contact for Moderna for your territory, analyzing and understanding • Recruit, onboard, coach, and lead a high-performing team of Regional Account Managers focused on driving growth and expanding access to Moderna’s respiratory vaccine portfolio (including COVID-19, RSV, and flu). •  Define and execute the regional go-to-market strategy across key customer segments, aligned with national commercial priorities. • Serve as the point of escalation for field contracting and pricing issues; collaborate with Legal, Finance, and Market Access to craft innovative access solutions and customer agreements. • Develop a high-performance culture by providing pipeline coaching, performance management, and ongoing development for field teams. • Capture and synthesize field intelligence to inform regional targeting strategies and contribute insights to national planning discussions across brand, pricing, and distribution. • Lead engagement strategies for large strategic accounts, public health coalitions, and government entities across your region. • Use data and digital tools to prioritize opportunities and monitor field performance, adapting quickly to emerging trends or needs. • Represent Moderna at high-level external engagements, including trade shows, advisory meetings, customer summits, and public health forums. • Partner as a peer with cross-functional leads across Medical Affairs, Marketing, Public Affairs, Distribution, and Customer Service to drive customer-centric execution. • Ensure full compliance with Moderna policies and all applicable healthcare laws and regulations. Here’s What You’ll Need (Basic Qualifications) • Bachelor’s Degree required • Minimum 10 years of experience in pharmaceutical/biotech commercial roles, including field account strategy • Minimum 5 years of experience directly managing field-based account teams Here’s What You’ll Bring to the Table (Preferred Qualifications) • Prior experience in vaccines is highly preferred • Experience launching new vaccines or therapeutics in dynamic or startup environments • Deep knowledge of key customer types including IDNs, state awardees, FQHCs, VFC, and risk-based providers • Proven ability to drive volume growth and profitability with large, complex customer accounts • Familiarity with value-based care principles and public-private partnerships • Strong cross-functional leadership experience (e.g., with Medical, Distribution, Marketing, and Public Affairs) • Experience in pricing, contracting, and/or access strategy development • Fluency in data-driven decision-making and CRM utilization for field strategy • High adaptability and comfort operating in ambiguity and a rapidly evolving healthcare landscape • Exceptional interpersonal, leadership, and influencing skills • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support • Family planning benefits, including fertility, adoption, and surrogacy support • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown • Savings and investment opportunities to help you plan for the future • Location-specific perks and extras The salary range for this role is $196,700.00 - $353,400.00(for positions that may be performed in California, the expected salary range is $286,440.00 - $329,560.00, which reflects the range permitted under California Labor Code requirements) . This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.  - #LI-Remote

Customer Relationship Management
Strategic Planning
Team Leadership
Verified Source
Posted 19 days ago
MO

Director, Clinical Operations, Therapeutics and Oncology

ModernaTbilisi, Georgia, Cambridge, Massachusetts, Princeton, New JerseyFull-time
View Job
Compensation$167K - 301K a year

Manage and oversee clinical programs, including vendor and CRO management, to ensure successful execution of oncology trials. | Minimum of 10 years of trial and clinical program experience, with at least 6 years in high complexity, global trial management, and specific expertise in oncology. | The Role: Moderna is seeking a Director of Clinical Operations to manage oncology programs which may consist of one or more studies. This is a clinical operations program management role. This position will be responsible for initiating and leading clinical programs, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations, Therapeutics and Oncology with a focus on oncology. This position will work collaboratively across the oncology development and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. Here’s What You’ll Do: Accountable for delivery of assigned clinical program budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs Support the selection, oversight, and management of CROs and other vendors Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders Perform and document study level Sponsor Oversight of outsourced clinical activities Communicate study-status, cost and issues to ensure timely decision-making by senior management Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna Support program level deliverables/activities Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff. Strive for continuous improvement and more efficient ways of working in clinical development Act as a role model for Moderna’s values Here’s What You’ll Bring to the Table: Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred. Robust experience in oncology required. Late-stage/phase 3 experience required. Experience in immuno-oncology is desirable but not required. Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc. Experience in GCP inspections/audits Outstanding verbal and written communication skills, in addition to excellent organizational skills Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry Resilient, Creative, capable problem-solver Excellent organizational skills and ability to work independently Experience in establishing and maintaining relationships with key opinion leaders Some travel required Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Clinical trial management
Oncology experience
Regulatory compliance
Direct Apply
Posted 24 days ago
Moderna

Principal Technical Program Manager, Digital CMC

ModernaCambridge, MAFull-time
View Job
Compensation$130K - 180K a year

Lead and coordinate large-scale software development programs across multiple engineering teams to deliver CMC digital products on schedule, ensuring technical and business requirements are met. | Requires 9+ years relevant experience, strong technical expertise in software delivery, knowledge of manufacturing and CMC systems, and ability to manage complex cross-functional programs in a regulated environment. | The Role The Digital CMC organization is looking to hire an experienced Technical Program Manager (TPM) who brings strong technical expertise, a product mindset that embodies the unique Moderna Mindsets and passion to change the future of medicine. In this role, you will work on exciting, cutting-edge technology initiatives/products from the ground up to empower our technology roadmap across the organization, with the ultimate goal of transforming patient lives. Here’s What You’ll Do Technical Program Managers at Moderna are agile delivery leaders that balance business intent with engineering and operational tactical activities, while building and optimizing product delivery schedules. They utilize dynamic range, technical depth, and agile practices to drive product launches through the entire software development lifecycle, including technical strategy, workstream decomposition, timelines, dependency management, reporting, and delivery risk mitigation. TPMs build and leverage close relationships with software engineers, product managers and key business partners to understand product priorities and ensure that all technical deliverables are met on a consistent basis. In this role, the TPM will drive programs and digital product launches that enables Moderna to make and sell our therapeutics commercially across the globe, directly impacting who has access to our medicines. This requires experience and strong working knowledge of how Moderna’s manufacturing processes and systems work, including systems such as DeltaV, MES, LIMS, Chromeleon, SAP, and other similar capabilities within the CMC domain. A successful candidate will have an established track record in customer facing, cross-functional program initiatives, have broad and deep technical knowledge, have demonstrated problem solving skills, excellent schedule/delivery management skills, great communication skills, and a motivation to achieve results in a fast paced collaborative environment. Additionally, a successful candidate will have the ability to quickly earn trust with the teams they engage with, foster a positive program environment, and come to each discussion, deliverable, and issue with a "can do" attitude. Key Responsibilities: • Program management of large scale complex initiatives through the entire development life cycle; planning, execution, status reporting and coordination against project plans and delivery commitments • Provide leadership and support for multiple engineering teams involved in building and supporting the CMC applications eco system. Engage the engineering teams and TPMs of various organizations to ensure that their iterations on design and development enable completion by needed deadlines. Assist in the execution through multiple iterations of product enhancements and delivery. • Work closely with platform engineering teams to ensure customer, business, and technology needs are met without compromising long term platform health and evolution • Coordinate and facilitate system architecture and design sessions with engineering, evangelize modern software architecture best practices • Facilitate roadmap development across the multiple product engineering teams and help shape the overall vision for Commercial Digital products to evolving global requirements, rules, and laws. • Facilitate launch planning across multiple teams to bring the project end points along multiple work streams into a single timeline to meet launch target dates • Coordinate with the product teams, business teams, and stakeholders to ensure that end-to-end verification and validation complete at the right time and in the correct environments to demonstrate readiness for launch • Coordinate with project/program managers from non-tech work streams to ensure that technical and non-technical plans and initiatives are coordinated and achieve the combined goals and business needs without negatively impacting the performance of the business teams and vendors in the execution of their duties Defining Product Requirements • Deeply understand customer and business needs and translate to technical requirements and develop the product’s trajectory, required resources, and budgets Solving Challenges • TPMs will identify cross-functional and cross-team dependencies and devise strategies to solve these challenges both at an organizational and technical level. Determining Product Timelines and Reporting • Honoring product timelines is key to timely delivery. TPMs carefully plan timelines based on product priority, complexity and various other factors. They also regularly monitor the progress of specific product tasks. Building Consensus and Finding Cutting-edge Solutions • TPMs work with software development engineers and managers within and across teams to drive consensus on technical requirements to ensure delivery. They also regularly take stock of various project-related tasks and review progress regularly. Analyzing and Mitigating Risks • TPMs regularly assess and identify potential product-related issues throughout the lifecycle of a product and plan effective strategies to mitigate risks to ensure smooth and timely delivery of outcomes Here’s What You’ll Need (Basic Qualifications) • Bachelor’s Degree in Computer Science, Engineering, Machine Learning, or a related field OR 5 years of equivalent professional experience in lieu of a degree • Minimum 9 years of relevant job experience • 2+ years of job-related experience in data analysis, capacity planning, strategy, and risk management • 5+ years of job-related experience in software delivery methodologies Here’s What You’ll Bring to the Table (Preferred Qualifications) • Prior experience in budgeting and project reporting • Domain expertise in several of: Manufacturing, Supply Chain, QC Labs, application lifecycle management • Demonstrated success in representing the voice of the customer. • Demonstrated ability to channel many points of view negotiating, cultivating and growing partnerships • Strong technical abilities; experienced with modern software development practices used to build and deploy applications • Demonstrated ability to work in a fast growing, multidisciplinary organization • Self-directed and self-motivated; excellent communicator and collaborator • Experience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in one or more of eCommerce, data/machine learning platforms, or cloud infrastructure • Evidence of Moderna Mindset: “We behave like owners. The solutions we're building go beyond any job description” • Evidence of Moderna Mindset: “We Act with dynamic range, driving strategy and execution at the same time at every step” • Evidence of Moderna Mindset: “We Prioritize the platform over any single solution” • Experience in a regulated environment • Experience working in a matrixed organization • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. • Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support • Lifestyle Spending Accounts to personalize your well-being journey • Family planning and adoption benefits • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown • Savings and investment opportunities • Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.  Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 -

Technical Program Management
Software Delivery Methodologies
Agile Practices
Program and Project Management
Risk Management
Manufacturing Systems (DeltaV, MES, LIMS, Chromeleon, SAP)
Cross-functional Team Leadership
Product Lifecycle Management
Verified Source
Posted 6 months ago

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