Director or Sr Director, Safety Science

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

The Director or Senior Director, Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. The position will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development portfolio. They will bring safety expertise to interactions with internal stakeholders and regulatory authorities and must have the ability to interact effectively in a multifunctional and multicultural team setting. Additionally, the Director or Sr Director, Safety Science will work closely with Safety Operations for case review, medical review, and study oversight for patient safety.   

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. 

Essential Duties and 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. 
• Contribute to the drafting of safety assessments and drug safety reports for individual cases or aggregate data for signals or in response to Regulatory Authority requests.  
• 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 re