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← Kymera Therapeutics

Global Safety Officer (Medical Director / Senior Medical Director)

Kymera Therapeutics
Location
Watertown, MA
Posted
25 days ago
Department
Development
Salary
$220,000 – $340,000
What they actually want (must-haves)
  • M.D. (or equivalent international medical degree)
  • Minimum 3–5 years (Medical Director) or 6+ years (Senior Medical Director) of pharmacovigilance/drug safety experience in the biotech/pharmaceutical industry, or equivalent clinical development experience with strong safety/benefit-risk exposure
  • Working knowledge of global PV regulations and safety reporting requirements, including FDA, EMA, and ICH E2 guidelines (E2A, E2B, E2C, E2E, E2F)
  • Hands-on experience with signal detection methodology, aggregate safety reporting (DSUR, PBRER/PSUR), and development/maintenance of risk management plans (RMPs)
  • Demonstrated experience authoring or substantively contributing to safety sections of regulatory submissions (IND/CTA, IB, NDA/BLA/MAA components)
  • Direct experience serving as a medical safety reviewer for individual case safety reports (ICSRs) and making expedited reporting determinations
Nice to have
  • Prior experience in immunology/inflammation and/or oncology therapeutic areas
  • Experience with small molecule and/or targeted protein degrader development programs
  • Prior experience supporting a marketing application (NDA/BLA/MAA) safety package
  • Board certification in a relevant clinical specialty (e.g., internal medicine, rheumatology, immunology)
What the job really is

The Global Safety Officer (GSO) at Kymera is responsible for overseeing the medical safety of assigned development programs throughout their lifecycle, from early clinical development to regulatory submission and post-marketing surveillance. This role involves collaborating with various departments to assess and communicate the benefit-risk profile of compounds, leading signal detection and safety reviews, and ensuring compliance with global safety regulations. The GSO will also represent patient safety in interactions with health authorities and contribute to regulatory submissions.

Benefits
  • Competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay
  • Anticipated base salary range of $220,000 – $340,000
  • Eligibility for annual bonus
  • Equity participation
  • Comprehensive benefits
Things to weigh
  • The role requires a high level of cross-functional collaboration and visibility, which may not suit all candidates.
  • The position is in a fast-paced, resource-lean environment, which may involve a significant workload and pressure to deliver results.
  • No specific details on the comprehensive benefits package are provided, which may require further inquiry during the interview process.
Job score4.4/5
Benefits3/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency5/5

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