Erasca, Inc.

Director

• Develop and maintain an understanding of the safety profile of assigned product(s) and relevant strategic context
• Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development plans
• Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports
• Contribute to drafting safety assessments and drug safety reports for individual cases or aggregate data and respond to Regulatory Authority requests
• Responsible for signal detection and management activities including ISMP maintenance
• Prepare and maintain 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
• Represent Medical Drug Safety in communication with health and regulatory authorities and at Data Safety Monitoring Committee meetings
• Evaluate risk minimization strategies and take accountability for medical-scientific content in Risk Management Plans, including REMS as relevant
• Review clinical protocols, study reports, Investigator's Brochure, informed consent forms and related documents to ensure alignment with safety strategy
• 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
• Support non-molecule projects, due diligence evaluations, and other projects as needed
• Coordinate and collaborate with vendors servicing Safety Science
• Accountable for safety components of study reports, publications, aggregate reports, and high-level regulatory documents
• Perform duties in keeping with company core values, policies, and applicable regulations

Director or Senior Director, Safety Science