Senior Director, Global Regulatory Strategy, Oncology

The Role

Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and registration strategies.

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.

• Lead global regulatory strategies from early development through commercialization
• Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency
• Lead health authority interactions (FDA, EMA, PMDA), including high-stakes negotiations
• Shape strategies for novel and first-in-class therapies
• Partner cross-functionally and across alliances to align on strategy
• Anticipate regulatory risks and proactively mitigate them
• Build and develop high-performing regulatory teams

• BA/BS degree in a scientific/engineering discipline
• 12+ years of experience in the Pharmaceutical industry
• 8+ years of experience in Regulatory strategy, including oncology
• Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
• Strong experience with CTD format and content regulatory filing
• Exceptional written and oral communication
• Experience with developing and implementing competitive regulatory strategies
• Demonstrated track record in securing product approvals and maintaining a complex portfolio
• Experience dealing with broad range of stakeholders at all levels internal and external to the company
• Demonstrated competence in employee management and development
• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both US and EU
• Direct experience of leading regulatory authority meetings in different phases of drug development

• Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
• Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
• Acts with urgency and delivers results with excellence
• Thinks and operates as an enterprise leader
• Challenges convention and drives innovation
• Makes high-quality decisions under ambiguity and pressure
• Builds and develops high-performing, accountable teams
• Influences effectively across internal and external stakeholders

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 $ - $. 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.

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.