Erasca, Inc. is hiring a
Assoc Director Safety Science

Summary

The Associate Director of Safety Science will provide safety science support to Erasca's portfolio, supporting early and late phase development activities and ensuring patient safety. The role requires a healthcare professional degree with at least 6 years of drug development experience, including at least 4 years in drug safety.

Requirements

• Healthcare professional degree (MD , PharmD , or x-US equivalent ) required
• 6 or more years of drug development experience in the pharmaceutical or related industry including at least 4 years in drug safety

Responsibilities

• Develop and maintain an expert understanding of the safety profile of assigned product(s) as well as understanding of the relevant strategic context
• Responsible for signal detection and management activities including, but not limited to , ISMP maintenance
• Contribute to the review of safety assessments and drug safety reports for individual cases or aggregate data for signals or in response to Regulatory Authority requests
• 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
• Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.)
• Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB
• Present important safety issues to program teams for internal and external review
• May support non-molecule projects, due diligence evaluations , and other projects as needed
• Responsible for coordination and collaboration with vendors servicing Safety Science
• Contribute to and/or lead the development of the safety components of the Target Product Profile (TPP), key claims , and other lifecycle strategic planning documents (e.g., CDP)
• 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

Benefits

• Paid Time Off , Holiday , and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability , Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Account s (FSA , HSA, and Commute )
• Critical Illness and Accident Coverage , Pet Insurance, Employee Assistance Program
• 401(k) Plan with Erasca contribution
• The opportunity to participate in an Employee Stock Purchase Program