Overview
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.
About the Role
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 regulatory submissions.
- Contribute to the development and review of scientific publications; author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
- Present at scientific, medical, and regulatory meetings.
- Maintain a high level of clinical and scientific expertise by reviewing literature, attending medical or scientific meetings, and through personal exchange with thought leaders, investigators, and internal stakeholders and partners.
- Participate in due diligence or other business development activities.
- Recruit, retain, and develop high-functioning late clinical development team.
- Establish, develop, and maintain relationships across Erasca, particularly with partners and stakeholders in Research and Development.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Required Education and Experience
- M.D. degree or equivalent, with subspecialty fellowship training and board certification or eligibility in Oncology or Oncology/Hematology.
- 12+ years of oncology clinical trial and drug development experience, including extensive experience in the pharmaceutical or biotechnology industry. The ideal candidate will bring a combination of clinical practice, academic clinical trials, and industry experience, with both large and small company experience a plus.
- Direct management of medical and scientific staff in clinical development required; experience leading medical affairs function highly preferred.
- Experience as the clinical lead on complicated global programs with multiple indications and studies required.
- Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required.
- Experience with product launch and commercialization highly preferred.
- Experience in early development a plus.
- Extensive knowledge of clinical trial methodology and the regulatory and compliance requirements governing clinical trials.
- Executive leadership skills to represent late development on LT, educate and influence stakeholders, and add value in strategic business planning and decision-making.
- Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment.
- Effective interpersonal, communication and influencing skills, including excellent writing skills, with the ability to tailor communication style to diverse audiences and situations.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
- Strong learning orientation, curiosity, and commitment to science and patients.
