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Jobs · Business Development · Massachusetts

Senior Director, Global Regulatory Strategy, Oncology

BioSpace · Cambridge, MA · 1 wk ago
Business DevelopmentFull-time

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.

Here's What You’ll Do

  • 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
  • Continuously elevate strategic thinking across programs and stakeholders
  • Interpret health authority feedback through a trend-based, cross-program lens
  • Connect individual HA interactions to a broader regulatory narrative
  • Bring regulatory thinking earlier into research and development and define success upfront
  • Proactively identify risks before they emerge in HA feedback
  • Navigate novel endpoints and evolving evidentiary frameworks
  • Operate effectively in complex global regulatory environments with limited precedent
  • Develop teams to operate with independence and strong strategic judgment

Here’s What You’ll Need (Basic Qualifications)

  • 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 filings
  • 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

Here’s What You’ll Bring to the Table (Preferred Qualifications)

  • 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.)

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

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.

Our Working Model

We are 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.

Equal Opportunities

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants regardless of criminal histories, religious beliefs, personal life choices, or any other personal characteristic protected under applicable law.

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.

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