Executive Director, Global Regulatory Strategy, Oncology

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

This is an opportunity to provide senior strategic leadership for global regulatory strategies supporting select early Oncology and Therapeutics programs, helping shape how innovative medicines progress from early development toward pivotal studies, registration, and lifecycle management.

As a senior leader within Global Regulatory Science, you will define forward-looking, scientifically rigorous regulatory strategies for complex and innovative therapeutic modalities, including mRNA-based therapies. You will anticipate evolving regulatory expectations, identify opportunities to accelerate development, and provide the regulatory perspective that informs critical portfolio, investment, and program decisions.

You will partner with senior leaders across Research, Clinical Development, Regulatory CMC, Safety, Translational Medicine, Commercial, and other functions, while representing Moderna in high-level interactions and negotiations with global Health Authorities. You will also provide strategic guidance, coaching, and mentorship to regulatory professionals and contribute to strengthening regulatory capabilities across the organization.

The role will offer opportunities to engage with Generative AI and emerging digital tools to strengthen regulatory intelligence, knowledge synthesis, scenario evaluation, and strategic decision-making.

Here's What You'll Do

• Serve as the senior Global Regulatory Lead for select strategically important oncology programs, with accountability for defining and driving innovative, integrated global regulatory strategies that enable efficient progression toward late-stage development and registration.
• Establish strategic regulatory direction across assigned oncology programs, ensuring strategies are scientifically sound, forward-looking, globally aligned, and consistent with Moderna's development and business objectives.
• Partner closely with program teams and executive leadership to identify and advance creative, science-driven regulatory approaches that accelerate development timelines, optimize clinical development plans, and establish efficient pathways toward registration.
• Shape early development plans, including clinical development strategies, key evidence-generation requirements, regulatory milestones, and the regulatory considerations required to enable successful transition into pivotal development.
• Anticipate and navigate complex regulatory challenges associated with innovative therapeutic modalities, including mRNA-based therapies.
• Monitor evolving global regulatory expectations and identify opportunities to leverage innovative regulatory pathways, expedited development programs, regulatory precedents, and emerging regulatory science approaches to accelerate development and approval.
• Serve as a trusted regulatory advisor to program teams and senior leadership, providing clear recommendations on complex regulatory challenges, strategic options, risks, opportunities, and trade-offs to inform critical program and investment decisions.
• Lead global Health Authority engagement strategies for assigned programs, including interactions with the FDA, EMA, and other regulatory agencies, to gain alignment on development plans, evidence requirements, and pathways toward registration.
• Represent Moderna in critical Health Authority meetings and negotiations, clearly articulating scientific and regulatory positions and advocating for innovative development approaches that support program objectives.
• Lead the development of regulatory positions and negotiation strategies and drive resolution of complex regulatory issues with Health Authorities.
• Provide strategic oversight of regulatory submissions and interactions, including investigational applications, briefing packages, regulatory correspondence, and other filings, ensuring quality, scientific rigor, and alignment with global regulatory strategies.
• Identify and lead the resolution of regulatory issues that could affect development timelines, clinical trial design, progression into pivotal studies, or future registration opportunities.
• Serve as a core member of assigned program teams, partnering closely with Clinical Development, Research, Regulatory CMC, Safety, Translational Medicine, and other functions to create integrated and innovative development strategies that balance scientific rigor, regulatory expectations, and speed to patients.
• Partner with executive leadership and program governance bodies to evaluate development scenarios, challenge conventional approaches, and recommend strategic options that accelerate program advancement while appropriately managing regulatory risk.
• Represent Global Regulatory Strategy in program governance and senior leadership discussions, communicating regulatory risks and opportunities and influencing critical development, portfolio, and investment decisions.
• Drive alignment across global and regional regulatory functions and external partners, as applicable, to ensure coordinated regulatory strategies, consistent Health Authority positions, and effective execution of program priorities.
• Provide strategic leadership, guidance, coaching, and mentorship to regulatory professionals, helping strengthen organizational capabilities and foster high performance, accountability, scientific curiosity, and strategic thinking.
• Support the development of regulatory capabilities in early development strategy, innovative regulatory pathways, and effective Health Authority engagement through coaching, knowledge sharing, and strategic guidance.
• Champion regulatory excellence across oncology programs and the broader Global Regulatory Science organization by promoting regulatory intelligence, best practices, and continuous learning.
• Monitor emerging regulatory policies, scientific developments, and industry trends relevant to oncology and innovative therapeutic modalities, translating those insights into actionable strategies that support accelerated development and regulatory innovation.
• Contribute to the continued evolution of regulatory capabilities, processes, and strategic excellence across Moderna.
• Explore and apply Generative AI and other emerging digital capabilities where appropriate to enhance regulatory intelligence, synthesize complex scientific and regulatory information, evaluate strategic scenarios, and improve the speed and quality of regulatory decision-making.

The key Moderna Mindsets you'll need to succeed in the role

• "We question convention because proven models don't always fuel the future."
• "We act with dynamic range, driving strategy and execution at the same time at every step."

Education and Experience

• Bachelor's degree in a scientific, medical, pharmaceutical, or related discipline required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.
• 15+ years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including significant experience leading global regulatory strategies for oncology programs.
• Extensive experience in oncology drug development, particularly early clinical development, with a demonstrated track record of advancing programs toward late-stage development, registration, and approval.
• Proven experience serving as a Global Regulatory Lead for complex development programs, including leading cross-functional regulatory strategy and contributing to major regulatory submissions and product approvals.
• Demonstrated experience leading, mentoring, and developing regulatory professionals.

Regulatory and Scientific Expertise

• Deep knowledge of global regulatory requirements and pathways for oncology drug development, particularly in the US and EU, including expedited development and approval programs.
• Demonstrated ability to develop innovative, science-driven regulatory strategies that optimize clinical development plans, accelerate development timelines, and establish efficient pathways to registration.
• Extensive experience leading Health Authority interactions and negotiations, including securing alignment on clinical development plans, pivotal trial designs, and regulatory requirements.
• Strong understanding of regulatory submission requirements, including investigational applications, CTD/eCTD formats, and major marketing applications (BLAs, NDAs, MAAs).
• Ability to critically evaluate complex scientific and clinical data, regulatory precedents, and emerging regulatory trends to inform strategic decisions.
• Experience with innovative therapeutic modalities, including mRNA-based therapies, immuno-oncology, or other emerging oncology technologies, preferred.

Leadership and Strategic Capabilities

• Proven ability to partner with program teams and executive leadership to challenge conventional approaches, evaluate innovative development scenarios, and influence critical program decisions.
• Exceptional strategic thinking, judgment, and problem-solving skills, with the ability to navigate ambiguity, anticipate regulatory challenges, and balance scientific, regulatory, and business considerations.
• Demonstrated ability to lead through influence, build cross-functional alignment, and drive decisions in a complex global organization.
• Exceptional communication and negotiation skills, with the ability to articulate compelling regulatory strategies and recommendations to senior executives, Health Authorities, and external stakeholders.
• Forward-looking, proactive, and collaborative leadership style, with a commitment to developing talent, fostering innovation, and advancing transformative medicines for patients.

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.

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 $224,900.00 - $404,600.00. 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.