Director or Sr Director, Safety Science

Role Summary

Director or Senior Director, Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. The role supports both early and late-phase development as a member of the safety team, delivering essential safety oversight and input into all aspects of study management across the development portfolio. You will bring safety expertise to interactions with internal stakeholders and regulatory authorities and collaborate effectively in a multifunctional, multicultural team. This position can be hybrid in San Diego or South San Francisco, or fully remote anywhere in the United States.

Responsibilities

• Develop and maintain an understanding of the safety profile of assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
• Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy aligned with clinical development plan(s).
• Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports.
• Responsible for signal detection and management activities including, but not limited to, ISMP maintenance.
• Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB.
• Contribute to regulatory authority submissions and provide medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.
• Represent Medical Drug Safety in communication with health and regulatory authorities and at independent Data Safety Monitoring Committee meetings.
• Evaluate risk minimization strategies and take accountability for the medical-scientific content in Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.
• Review clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
• Present important safety issues to program teams for internal and external review.
• Serve as safety science representative for clinical trial team meetings or investigator/site meetings.
• May support non-molecule projects, due diligence evaluations, and other projects as needed.
• Responsible for coordination and collaboration with vendors servicing Safety Science.
• Accountable for the safety components of study reports, publications, aggregate reports, and high-level regulatory documents.
• Perform all duties in keeping with the Company's core values, policies, and all applicable regulations.

Qualifications

• Healthcare professional degree required. MD or PharmD highly preferred, other relevant clinical degrees may be considered.
• 6 or more years of drug development experience in the pharmaceutical or related industry including at least 4 years in drug safety for oncology clinical development.
• Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management is essential.
• Expert knowledge of regulations governing pharmacovigilance.
• Exposure to Safety Operations and experience with data entry and administration of drug safety databases, such as Oracle Argus, a plus.
• In depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation; exposure to early clinical development preferred.
• Experience interacting with regulatory authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums required; filing experience highly preferred.
• Strong presentation skills, effective at summarizing and presenting key considerations and decision points.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Strong learning orientation, curiosity, and commitment to science and patients.