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

The role

The Medical Director serves as the Global Medical Safety Lead providing strategic and medical leadership for safety surveillance and risk management of assigned products. This role involves signal detection, benefit-risk assessment, and leading cross functional Safety Management Teams.

What you will do

• Direct the planning, preparation, writing and review of safety aggregate reports, including DSUR.
• Train and support qualified PSRM staff on medical review, safety surveillance activities and authoring of aggregate reports.
• Provide benefit-risk assessment on potential safety signal or in safety documents/reports.
• Lead product benefit-risk assessment discussions at safety management meetings.
• Lead cross functional safety management team meetings and escalate safety issues.
• Contribute to the development of Investigator Brochures, Protocols, Subject Informed Consent, statistical analysis plans, integrated safety summary, RMP/REMS, and other study related documents.
• Support and collaborate with cross functional teams on safety related activities including providing responses to safety related queries from regulatory authorities and IRB/EC.
• Ensure compliance with regulatory guidelines and internal processes and procedures.
• Serve as SME in audits and inspections.
• Serve as back-up medical review/sponsor approval of ICSRs.

Required qualifications

• MD, DO or medical degree from an accredited medical school
• Completion of an accredited medical or surgical residency or clinical experience in either academic setting or private practice
• A minimum of drug safety experience 7-10 years 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

Nice to have

• Prior NDA filing (ISS drafting and review) experience

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.