Assoc Director Safety Science

erasca · San Diego, South San Francisco, or remote · South San Francisco, California, United States · Remote · San Diego, California, United States

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<div class="content-intro">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.</div>Associate Director Safety Science Position Summary:   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.  Essential Duties and Responsibilities:   <ul> <li>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) </li> <li>Responsible for assisting/overseeing signal detection and management activities including, but not limited to, ISMP maintenance.</li> <li>Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB. </li> <li>Present important safety issues to program teams for internal and external review. </li> <li>Serve as safety science representative for clinical trial team meetings or investigator/site meetings</li> <li>

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