Medical Director/Senior Medical Director, Patient Safety & Risk Management

About the Role

The Medical Director, Patient Safety & Risk Management at Relay Therapeutics serves as the Global Medical Safety Lead (GSL) and provides strategic and medical leadership for safety surveillance and risk management of assigned products throughout their lifecycle. The GSL evaluates, interprets, and communicates safety information; conducts signal detection and management; performs benefit‑risk assessments; and develops risk‑minimization strategies to ensure patient safety and regulatory compliance. The role also supports medical review of individual case safety reports and safety surveillance activities, and leads the cross‑functional Safety Management Team.

Responsibilities

• Direct planning, preparation, writing, and review of safety aggregate reports, including DSURs.
• Train, collaborate with, and support qualified PSRM staff on medical review, safety surveillance activities, and authoring of aggregate reports.
• Provide benefit‑risk assessments on potential safety signals and lead product benefit‑risk discussions at safety management meetings.
• Lead cross‑functional safety management team meetings, escalate safety issues, and present safety issues and recommendations to executive decision‑making bodies.
• Contribute to the development of Investigator Brochures, protocols, subject informed consent, statistical analysis plans, integrated safety summaries, RMP/REMS, and other study‑related documents.
• Support and collaborate with cross‑functional teams on safety‑related activities, including responding to safety queries from regulatory authorities and IRBs/ECs.
• Ensure compliance with regulatory guidelines and internal processes, maintain inspection readiness, and serve as SME during audits and inspections.
• Serve as backup for medical review/sponsor approval of individual case safety reports (ICSRs) and ensure appropriate medical evaluation of emerging safety trends.

Qualifications

• MD, DO, or equivalent medical degree from an accredited medical school with completion of an accredited residency or equivalent clinical experience.
• 7–10 years of drug safety experience in the pharmaceutical industry.
• Experience leading cross‑functional teams or projects.
• Expertise in analyzing and presenting complex medical‑scientific data from a broad range of sources.
• Medical leadership and strategic review experience for aggregate safety reports (DSUR, PBRER/PSUR).
• Knowledge of global risk‑management planning, including RMPs and REMS, and risk‑minimization strategies.
• Expertise in global regulations governing safety surveillance and risk management.
• Prior NDA filing experience (ISS drafting and review) strongly preferred.

Pay

Estimated Salary Range: $201,000 – $351,000. The actual base salary will depend on factors such as education, experience, skills, and location.

About Relay Therapeutics

Relay Therapeutics is a clinical‑stage precision‑medicine company transforming drug discovery by leveraging insights into protein motion and its relationship to function. The company focuses on developing transformative therapies, initially targeting oncology, using its Dynamo platform that integrates experimental and computational approaches to understand protein structure and dynamics. Relay’s world‑class team collaborates across disciplines to bring life‑changing therapies to patients.