Senior Director, Global Regulatory Strategy, Oncology

The Role Moderna is seeking an experienced regulatory leader to lead development and execution of global regulatory strategy for a late-stage asset its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and registration strategies. This individual will have primary regulatory accountability for the asset and responsibility to shape and execute regulatory pathways designed to enable successful global development, approval, and lifecycle management of a novel, first-in-class therapeutic. The Senior Director will serve as a senior regulatory leader on the cross-functional asset team and will work closely with external alliance partners to ensure alignment on regulatory strategy, key development decisions, and execution priorities. The role will also be responsible for monitoring the evolving global regulatory and policy landscape relevant to oncology development and proactively shaping the external environment where appropriate, translating emerging policy, precedent, and health authority expectations into actionable strategies for the asset. This role requires a seasoned regulatory leader who embodies Moderna’s leadership principles: acting with urgency, challenging convention, delivering with excellence, and operating as an enterprise leader. The individual will demonstrate executive presence, deep functional expertise, and a strong execution track record while elevating strategic impact across programs. Here's What You’ll Do Lead the development and execution of the global regulatory strategy for Moderna’s lead oncology asset through late-stage development, registration, approval, and commercialization readiness Serve as the primary regulatory strategic lead and accountable regulatory representative for the asset, ensuring an integrated global regulatory strategy aligned with the overall development and product strategy Drive regulatory submissions, including INDs, CTAs, BLAs/NDAs, MAAs and other major global applications, with excellence and urgency Lead global health authority interactions, including with FDA, EMA, PMDA and other key agencies, and lead high-stakes regulatory negotiations at critical development and registration milestones Lead regulatory strategy and engagement within external alliances and partnerships, ensuring alignment between Moderna and alliance partners on regulatory objectives, positions, deliverables, governance decisions, and health authority interactions Represent Regulatory in relevant alliance governance forums, effectively navigating differing perspectives and influencing decisions to advance the asset’s development and registration objectives Partner closely with Clinical Development, Biostatistics, Safety, CMC, Commercial, Medical, Market Access, Legal, Policy and Alliance Management to ensure an integrated asset strategy and coordinated execution Partner with Regulatory Policy and other internal stakeholders to develop and advance external regulatory policy positions and shaping strategies in areas material to the asset and broader oncology portfolio Interpret health authority feedback through a trend-based, cross-program and external-landscape lens and connect individual interactions to the broader regulatory narrative for the asset Anticipate regulatory risks and opportunities and proactively develop mitigation or acceleration strategies before they affect program execution Bring regulatory thinking early into key development and business decisions and clearly define regulatory success criteria and decision points Provide regulatory leadership for registration readiness and global launch planning, including sequencing of major applications and alignment of regional strategies with the global asset strategy Develop regulatory strategies supporting post-approval commitments, lifecycle management, label expansion and future indications as appropriate Communicate complex regulatory issues, strategic options, risks, and recommendations clearly to senior management and governance bodies Build, lead, and develop high-performing regulatory teams and ensure team members operate with independence, accountability, and strong strategic judgment Continuously elevate strategic regulatory thinking across programs, functions, alliance partners, and stakeholders Here’s What You’ll Need (Basic Qualifications) BA/BS degree in a scientific, engineering, or related discipline 12+ years of experience in the pharmaceutical or biotechnology industry 8+ years of experience in Regulatory Strategy, including significant experience in oncology Strong knowledge of current US and EU regulatory requirements and experience applying novel and innovative regulatory pathways Strong experience with CTD format and content and preparation of major regulatory filings Direct experience leading regulatory authority meetings across different phases of drug development, including late-stage development and pre-submission/registration interactions Experience developing and implementing competitive and differentiated regulatory strategies Demonstrated track record in securing product approvals and/or leading major late-stage regulatory submissions Experience working with a broad range of stakeholders at all levels internal and external to the company Demonstrated ability to lead effectively within complex alliances or external partnerships and influence outcomes without direct authority Broad knowledge and experience with regulatory procedures and legislation for drug development, product registration, line extensions, and license maintenance, preferably across both the US and EU Ability to assess evolving regulatory and policy environments and translate external developments into actionable asset-level strategy Exceptional written and oral communication skills Demonstrated competence in employee management, coaching, and development Here’s What You’ll Bring to the Table (Preferred Qualifications) Graduate degree in a scientific discipline or other relevant graduate discipline, or relevant professional certification Delivery of at least one major marketing application (NDA/BLA/MAA/JNDA or equivalent) Experience navigating first-in-class products, novel modalities, novel endpoints, or evolving regulatory precedent Experience working in a co-development, co-commercialization, or other strategic alliance environment Experience contributing to regulatory policy development, external engagement, or industry initiatives relevant to oncology drug development Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, 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 investments 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. 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. 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