The Opportunity:The Medical Director, Patient Safety & Risk Management at Relay Therapeutics will serve as the Global Medical Safety Lead (GSL) and provides strategic and medical leadership for the safety surveillance and risk management of Relay Therapeutic assigned products throughout the product lifecycle. This role is responsible for the evaluation, interpretation, and communication of safety information; signal detection and management; benefit-risk assessment; and development of risk minimization strategies to ensure patient safety and regulatory compliance. In addition, the GSL will support the medical review of individual case safety reports and safety surveillance activities as needed for assigned Relay Therapeutic products. The GSL will lead the cross functional Safety Management Team in the evaluation of safety signals and implementation of risk minimization activities for Relay Therapeutic products.
We are seeking a safety physician, who thrives in a dynamic, agile biotech environment. Reporting to the Executive Director, Patient Safety & Risk Management, this individual serve as a key collaborator and leader in cross functional clinical program teams, including Clinical Development, Clinical Operations, Biostats, Data Management and Regulatory Affairs. The successful candidate will play a critical role in advancing the development of transformative therapies by providing medical safety expertise.
Your Role: - Direct the planning, preparation, writing and review of safety aggregate reports, including DSUR.
- Train/collaborate 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 and leads product benefit-risk assessment discussions at safety management meetings.
- Lead cross functional safety management team meetings and escalate safety issues including preparing and presenting of safety issue and recommendation to the executive decision-making body.
- 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, to be inspection ready and serve as SME in audits and inspections.
- Serve as back-up medical review/sponsor approval of ICSRs and ensure appropriate medical evaluation of individual case safety reports and emerging safety trends.
Your Background: - MD, DO or medical degree from an accredited medical school and 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 required
- Experience providing medical leadership and strategic review of aggregate safety reports (DSUR, PBRER/PSUR) is required
- Knowledge of global risk management planning including RMPs, REMS (Risk Evaluation and Mitigation strategies) and risk minimization strategies required
- Expertise in global regulations governing safety surveillance and risk management
- Prior NDA filing (ISS drafting and review) experience strongly preferred
Estimated Salary Range: [$201,000 - $351,000].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
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