About the RoleThe Global Safety Officer (GSO) serves as the core medical safety expert and strategic safety lead for one or more assigned Kymera development programs across their full lifecycle - from early clinical development through regulatory submission and, as applicable, post-marketing surveillance. This is a highly cross-functional, high-visibility role at a fast-moving clinical-stage company, requiring a physician-scientist who can operate with the rigor of a large pharma safety function while thriving in the agility and resourcefulness required of a growth-stage biotech.
The GSO will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Pharmacology, and external safety vendors/CROs to proactively characterize, monitor, and communicate the benefit-risk profile of assigned Kymera compounds, and will represent Patient Safety in interactions with Health Authorities, Data Monitoring Committees, and Kymera's Safety Management Team.
Title (Medical Director vs. Senior Medical Director) will be commensurate with the selected candidate's experience.
Key ResponsibilitiesSafety Strategy & Benefit-Risk Leadership- Serve as the accountable medical safety expert for one or more assigned investigational products, owning the strategic safety plan across the product lifecycle
- Lead ongoing benefit-risk assessment and ensure it is clearly and consistently reflected in clinical, regulatory, and safety documents
- Provide medical safety input into clinical development plans, protocols, statistical analysis plans, and investigator brochures
Signal Detection & Aggregate Safety Review- Lead signal detection, evaluation, and management activities
- Direct aggregate safety data reviews (e.g., blinded/unblinded data review, DSUR/PBRER, ad hoc safety reviews) and drive appropriate risk mitigation actions
- Participate in the safety governance activities: chair or co-chair internal Safety Management Team meetings and present at the Executive Safety Committee for assigned products
Risk Management & Regulatory Interface- Develop and maintain risk management plans (RMPs) and associated risk minimization strategies
- Author or contribute to key safety sections of regulatory submissions (IND/CTA, briefing documents, NDA/BLA/MAA components, responses to Health Authority queries)
- Represent Patient Safety in interactions with FDA, EMA, and other regulatory authorities, as well as with external Data Monitoring Committees (DMCs)
Case-Level & Compliance Oversight- Provide medical review and assessment of individual case safety reports (ICSRs), including expedited reporting determinations, in partnership with PV operations
- Ensure safety surveillance activities and periodic reporting remain compliant with applicable global regulations and Kymera safety standard operating procedures
- Support inspection and audit readiness for safety-related activities
Cross-Functional & External Collaboration- Partner closely with Clinical Development, Regulatory, Biostatistics/Data Science, Clinical Pharmacology, Quality, and Legal on all matters affecting product safety
- Stay current on relevant literature, competitive safety landscape, and evolving global PV regulations affecting assigned therapeutic areas
Required Qualifications- 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
- Demonstrated ability to synthesize complex clinical and safety data into clear, actionable benefit-risk assessments
- Experience representing safety positions directly to Health Authorities, Data Monitoring Committees, or equivalent external bodies
- Strong written and verbal communication skills, with the ability to present complex safety data clearly to cross-functional and senior stakeholders
- Proven track record operating effectively in a fast-paced, resource-lean biotech environment, balancing strategic thinking with hands-on, individual-contributor execution
- Strong collaborator with demonstrated success partnering across Clinical Development, Regulatory Affairs, Biostatistics, and Quality functions
Preferred Qualifications- 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)
Compensation
- Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
- The anticipated base salary range for this role is $220,000 - $340,000 with eligibility for annual bonus, equity participation, and comprehensive benefits.
