Associate Director, Stability Lead Development & Clinical

Moderna

Norwood, Massachusetts, US
$142,500.00 - $256,500.00; bonus/equity: eligible ...
**
Phase-appropriate stability strategies
Mrna portfolio
Ich guidance and regulatory expectations
** Moderna is seeking an Associate Director, Stability Lead Development & Clinical to define and execute stability strategies for a diverse mRNA portfolio. The role requires a deep understanding of scientific principles and regulatory standards, along with strong leadership skills to manage cross-functional teams. **

Job Summary

  • Define and lead phase-appropriate stability strategies aligned to development, clinical, or commercial program objectives, ensuring strong scientific and regulatory positioning across the portfolio.
  • Lead stability data review, including statistical evaluation and trending analysis, to support defensible shelf-life assignments, expiry updates, storage conditions, and risk-based recommendations.
  • Partner closely with Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align stability strategies with program and business needs.

Matching Summary

Match Score: 75

** Moderna is seeking an Associate Director, Stability Lead Development & Clinical to define and execute stability strategies for a diverse mRNA portfolio. The role requires a deep understanding of scientific principles and regulatory standards, along with strong leadership skills to manage cross-functional teams. **

Salary

$142,500.00 - $256,500.00; Bonus/Equity: Eligible for annual discretionary bonus, other incentive compensation, or equity award; Benefits: Best-in-class healthcare, well-being resources, family planning, generous paid time off, savings and investment opportunities

Skills & Requirements

Must-have

  • phase-appropriate stability strategies
  • mRNA portfolio
  • ICH guidance and regulatory expectations
  • stability data review and trending
  • shelf-life assignments
  • cross-functional subject matter expert

Nice-to-have

  • emerging degradation trends
  • proactive mitigation strategies
  • digital tools and advanced analytics
  • generative AI capabilities

Key Requirements

  • 12 years of relevant experience with Bachelor’s degree or 5 years of relevant experience with a PhD
  • Advanced degree preferred with 7+ years of relevant industry experience
  • Significant experience leading stability strategy for biologics, vaccines, or complex drug products
  • Experience authoring stability content for major regulatory submissions
  • Experience operating within cross-functional CMC team structures
  • Experience with statistical analysis and stability trending
  • US person eligibility for export control

Work Rights

US person eligibility for export control

Tailored Resume

Cover Letter