Assoc Director Safety Science

Erasca•San Diego, CA

1d•$190,000 - $255,000•Hybrid

About The Position

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. Reporting to the Director, Safety Science, the Associate 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 Associate 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.

Requirements

Healthcare professional degree (MD, PharmD, or RN) required
4 or more years of drug development experience in the pharmaceutical or related industry including at least 2 years in drug safety
Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management is essential
Demonstrated ability to lead and influence, with and without authority, in a fast paced environment
Exposure to Safety Operations and experience with data entry and administration of drug safety databases, such as Oracle Argus
Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
Proven ability to effectively train others on departmental practices and processes
Strong learning orientation, curiosity, and commitment to science and patients

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)
Responsible for assisting/overseeing 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.
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
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.
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.
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.