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Salary: USD 201,000 - 351,000 / annual
Relay Therapeutics, a clinical-stage precision medicines company, is seeking a Medical Director/Senior Medical Director for Patient Safety & Risk Management. This role serves as the Global Medical Safety Lead (GSL) and provides strategic medical leadership for safety surveillance and risk management of assigned products throughout their lifecycle.
The Medical Director will be responsible for evaluating, interpreting, and communicating safety information; detecting and managing safety signals; conducting benefit-risk assessments; and developing risk minimization strategies to ensure patient safety and regulatory compliance. The GSL will support medical review of individual case safety reports (ICSRs) and lead cross-functional Safety Management Teams in evaluating safety signals and implementing risk minimization activities.
Key responsibilities include:
- Directing planning, preparation, writing, and review of safety aggregate reports, including DSUR (Development Safety Update Report)
- Training and collaborating with PSRM staff on medical review and safety surveillance activities
- Providing benefit-risk assessments on potential safety signals and leading product benefit-risk discussions at safety management meetings
- Leading cross-functional safety management team meetings and escalating safety issues to executive decision-making bodies
- Contributing to development of Investigator Brochures, protocols, informed consent forms, statistical analysis plans, integrated safety summaries, RMP/REMS, and related documents
- Supporting and collaborating with cross-functional teams on safety-related activities, including responses to regulatory authorities and IRB/EC queries
- Ensuring compliance with regulatory guidelines and internal processes; serving as subject matter expert in audits and inspections
- Serving as backup for medical review and sponsor approval of ICSRs and ensuring appropriate evaluation of individual case safety reports and emerging safety trends
Reporting to the Executive Director of Patient Safety & Risk Management, this individual will serve as a key collaborator and leader in cross-functional clinical program teams, including Clinical Development, Clinical Operations, Biostats, Data Management, and Regulatory Affairs.
REQUIREMENTS:
- MD, DO, or medical degree from an accredited medical school with completion of an accredited medical or surgical residency or clinical experience in academic or private practice settings
- Minimum 7-10 years of drug safety experience in the pharmaceutical industry
- Experience leading cross-functional teams and/or projects
- Expertise in analyzing and presenting complex medical-scientific data from broad range of sources
- Experience providing medical leadership and strategic review of aggregate safety reports (DSUR, PBRER/PSUR)
- Knowledge of global risk management planning including RMPs, REMS (Risk Evaluation and Mitigation Strategies), and risk minimization strategies
- Expertise in global regulations governing safety surveillance and risk management
- Prior NDA filing (ISS drafting and review) experience strongly preferred
