SVP Late Clinical Development

About this role

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 Chief Medical Officer, the SVP Late Clinical Development will provide medical leadership and oversight of late-stage clinical trials and collaborate with the CMO across the Erasca portfolio. In addition, the SVP will be a hands–on drug developer and will serve as clinical lead and/or medical monitor on programs or studies. A key area of focus will be the design and execution of multiple registration enabling trials in solid tumor indications.

Essential Duties and Responsibilities:

• Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of late-stage clinical programs and contribute to clinical decision making across the Erasca portfolio. Participate in building and maintaining a culture of rigorous data-driven decision making.

• Lead late clinical development function, directly and through reports.

• Responsibilities will include clinical development strategy, protocol development, registrational strategy, KOL and academic site interactions, competitive landscape diligence, presentation of data, and other clinical deliverables.

• Serve as Medical lead on clinical programs and represent Clinical Development on program teams.

• Design and implement novel and efficient registration enabling clinical trials to assess appropriate endpoints.

• Responsible for leading clinical study subteams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.

• In collaboration with head of Medical Affairs, continue the establishment and execution of medical affairs strategy and tactics.

• Contribute to regulatory filings including authoring clinical sections for NDAs and other related documents.

• Partner with Drug Safety to assess the safety profile of compounds.

• Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and…