Global Safety Officer (Medical Director / Senior Medical Director)
Kymera Therapeutics
August 26, 2026
Remote friendly (Greater Boston)
United States
Medical Affairs
About The Role
The Global Safety Officer (GSO) is the core medical safety expert and strategic safety lead for assigned development programs across the product lifecycle (early clinical development through regulatory submission and, as applicable, post-marketing surveillance).
Key Responsibilities
- Serve as accountable medical safety expert for assigned investigational products; own the strategic safety plan across the product lifecycle
- Lead benefit-risk assessment and ensure consistency across clinical, regulatory, and safety documents
- Provide medical safety input into clinical development plans, protocols, statistical analysis plans, and investigator brochures
- Lead signal detection, evaluation, and management
- Direct aggregate safety data reviews (e.g., blinded/unblinded review, DSUR/PBRER, ad hoc reviews) and drive risk mitigation actions
- Participate in safety governance (chair/co-chair Safety Management Team; present to Executive Safety Committee)
- Develop/maintain risk management plans (RMPs) and risk minimization strategies
- Author/contribute safety sections of regulatory submissions and responses to Health Authority queries
- Represent Patient Safety with FDA, EMA, and other authorities and external DMCs
- Provide medical review of individual case safety reports (ICSRs), including expedited reporting determinations (with PV operations)
- Ensure safety surveillance and periodic reporting compliance with global regulations and SOPs; support audit/inspection readiness
- Partner with Clinical Development, Regulatory, Biostatistics/Data Science, Clinical Pharmacology, Quality, and Legal on product safety
Required Qualifications
- D. (or equivalent international medical degree)
- 3–5 years (Medical Director) or 6+ years (Senior Medical Director) pharmacovigilance/drug safety or equivalent clinical development safety/benefit-risk experience
- Working knowledge of global PV regulations and FDA/EMA/ICH E2 (E2A, E2B, E2C, E2E, E2F)
- Hands-on signal detection, aggregate safety reporting (DSUR, PBRER/PSUR), and RMPs
- Experience authoring/substantively contributing safety sections of IND/CTA, IB, NDA/BLA/MAA
- Experience as medical safety reviewer for ICSRs and expedited reporting determinations
- Ability to synthesize complex clinical/safety data into actionable benefit-risk assessments
- Experience representing safety positions to Health Authorities and DMCs
- Strong written/verbal communication with senior stakeholders
- Proven success in fast-paced, resource-lean biotech; cross-functional collaborator
Preferred Qualifications
- Experience in immunology/inflammation and/or oncology
- Experience with small molecule and/or targeted protein degrader programs
- Experience supporting NDA/BLA/MAA safety packages
- Board certification in a relevant specialty
Compensation
- Anticipated base salary range: $220,000–$340,000; eligibility for annual bonus, equity participation, and comprehensive benefits
The Global Safety Officer (GSO) is the core medical safety expert and strategic safety lead for assigned development programs across the product lifecycle (early clinical development through regulatory submission and, as applicable, post-marketing surveillance).
Key Responsibilities
- Serve as accountable medical safety expert for assigned investigational products; own the strategic safety plan across the product lifecycle
- Lead benefit-risk assessment and ensure consistency across clinical, regulatory, and safety documents
- Provide medical safety input into clinical development plans, protocols, statistical analysis plans, and investigator brochures
- Lead signal detection, evaluation, and management
- Direct aggregate safety data reviews (e.g., blinded/unblinded review, DSUR/PBRER, ad hoc reviews) and drive risk mitigation actions
- Participate in safety governance (chair/co-chair Safety Management Team; present to Executive Safety Committee)
- Develop/maintain risk management plans (RMPs) and risk minimization strategies
- Author/contribute safety sections of regulatory submissions and responses to Health Authority queries
- Represent Patient Safety with FDA, EMA, and other authorities and external DMCs
- Provide medical review of individual case safety reports (ICSRs), including expedited reporting determinations (with PV operations)
- Ensure safety surveillance and periodic reporting compliance with global regulations and SOPs; support audit/inspection readiness
- Partner with Clinical Development, Regulatory, Biostatistics/Data Science, Clinical Pharmacology, Quality, and Legal on product safety
Required Qualifications
- D. (or equivalent international medical degree)
- 3–5 years (Medical Director) or 6+ years (Senior Medical Director) pharmacovigilance/drug safety or equivalent clinical development safety/benefit-risk experience
- Working knowledge of global PV regulations and FDA/EMA/ICH E2 (E2A, E2B, E2C, E2E, E2F)
- Hands-on signal detection, aggregate safety reporting (DSUR, PBRER/PSUR), and RMPs
- Experience authoring/substantively contributing safety sections of IND/CTA, IB, NDA/BLA/MAA
- Experience as medical safety reviewer for ICSRs and expedited reporting determinations
- Ability to synthesize complex clinical/safety data into actionable benefit-risk assessments
- Experience representing safety positions to Health Authorities and DMCs
- Strong written/verbal communication with senior stakeholders
- Proven success in fast-paced, resource-lean biotech; cross-functional collaborator
Preferred Qualifications
- Experience in immunology/inflammation and/or oncology
- Experience with small molecule and/or targeted protein degrader programs
- Experience supporting NDA/BLA/MAA safety packages
- Board certification in a relevant specialty
Compensation
- Anticipated base salary range: $220,000–$340,000; eligibility for annual bonus, equity participation, and comprehensive benefits