VP Clinical Development and Global Program Lead (GPL) for Lung Cancer

Reporting to the Chief Medical Officer, the VP Clinical Development and Global Program Lead (GPL) for Lung Cancer will provide medical leadership and oversight of the lung cancer development program and collaborate with the CMO across the Erasca portfolio. Responsibilities will include clinical development strategy, protocol development, registrational strategy and execution, KOL and academic site interactions, competitive landscape diligence, presentation of data, and other clinical deliverables. In addition, the VP will be a hands-on drug developer and will serve as clinical lead and/or medical monitor on individual studies.

Essential Duties and Responsibilities:

• Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of the lung cancer program and contribute to clinical decision making across the Erasca portfolio. Participate in building and maintaining a culture of rigorous data-driven decision making.
• Lead the clinical development subteam for all studies in lung cancers.
• Design and implement novel and efficient 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.
• Provide overall strategy for clinical aspects of registrational strategies, interactions, and filings. Contribute to global regulatory filings and health authority interactions, including authoring clinical sections for INDs, NDAs and other related documents.
• Serve as Medical lead on clinical programs and represent Clinical Development on program teams.
• Partner with Drug Safety to assess the safety profile of compounds.
• Write or partner in the authoring of 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.
• Hire, develop, and mentor a high functioning team of medical directors and clinical scientists.
• 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 required. Additional training and clinical practice experience in thoracic oncology preferred.
• 8-10+ 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.
• Experience as the clinical lead on late-stage clinical programs in lung cancer highly preferred.
• Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required.
• Exposure to early development and the transition from FIH to registrational trials preferred.
• Extensive knowledge of clinical trial methodology and the regulatory and compliance requirements governing clinical trials.
• Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment.
• Executive leadership skills to educate and influence stakeholders and to add value in strategic business planning and decision-making.
• 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.