Associate 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. Their programs target novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, affecting approximately 5.5 million lives globally each year.

The Associate Director Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. Reporting to the Director, Safety Science, this role supports early and late-phase development activities, offering essential safety oversight and input into all aspects of study management across the entire development portfolio.

Key responsibilities include:

• Develop and maintain an understanding of the safety profile of assigned product(s), including the disease under study, safety profile of competitors, and mechanism of action.
• Assist/oversee signal detection and management activities, including maintenance of the Individual Case Safety Report (ISMP).
• Prepare and maintain safety sections of the ISMP, DSUR, IND Annual reports, and Reference Safety Information in the Investigator’s Brochure (IB).
• Present important safety issues to program teams for internal and external review.
• Serve as the safety science representative for clinical trial team meetings or investigator/site meetings.
• Contribute to drafting safety assessments and drug safety reports for individual cases, aggregate data for signals, or in response to Regulatory Authority requests.
• Review clinical protocols, study reports, Investigator’s Brochure (IB), informed consent forms (ICF), and other related documents to ensure alignment with safety strategy and risk management.
• Support non-molecule projects, due diligence evaluations, and other projects as needed.
• Coordinate and collaborate with vendors servicing Safety Science.
• Ensure safety components of study reports, publications, aggregate reports, and high-level regulatory documents are accurate.
• Perform all duties in compliance with company policies and applicable regulations.

Education and Experience:

• A healthcare professional degree (MD, PharmD, or RN) is required.
• 4+ years of drug development experience in the pharmaceutical or related industry, including at least 2 years in drug safety.
• Broad understanding of scientific aspects of safety, pharmacovigilance (GVP, GCP), and clinical/patient risk management.
• Demonstrated ability to lead and influence in a fast-paced environment.
• Experience with Safety Operations and familiarity with data entry and administration of drug safety databases, such as Oracle Argus.
• Strong presentation skills and ability to summarize and present key considerations.
• Proven ability to train others on departmental practices and processes.
• Strong learning orientation, curiosity, and commitment to science and patients.