Role Description
Reporting to the Chief Medical Officer, the VP Clinical Development and Global Program Lead (GPL) for GI Cancers will provide medical leadership and oversight of the pancreatic and colorectal cancer development programs and collaborate with the CMO across the Erasca portfolio. Responsibilities will include:
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Clinical development strategy
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Protocol development
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Registrational strategy and execution
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KOL and academic site interactions
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Competitive landscape diligence
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Presentation of data
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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.
Qualifications
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M.D. degree or equivalent, with subspecialty fellowship training and board certification or eligibility in Oncology or Oncology/Hematology required.
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8-10+ years of oncology clinical trial and drug development experience, including extensive experience in the pharmaceutical or biotechnology industry.
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Experience as the clinical lead on late-stage clinical programs in colorectal, pancreatic, or other GI cancers required.
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Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required.
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Exposure to early development and the transition from FIH to registrational trials preferred.
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Extensive knowledge of clinical trial methodology and the regulatory and compliance requirements governing clinical trials.
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Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment.
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Executive leadership skills to educate and influence stakeholders and to add value in strategic business planning and decision-making.
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Effective interpersonal, communication and influencing skills, including excellent writing skills.
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Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
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Strong learning orientation, curiosity, and commitment to science and patients.
Requirements
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Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of the pancreatic and colorectal cancer programs.
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Participate in building and maintaining a culture of rigorous data-driven decision making.
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Lead the clinical development subteam for all studies in GI cancers.
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Design and implement novel and efficient clinical trials to assess appropriate endpoints.
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Responsible for leading clinical study subteams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.
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Provide overall strategy for clinical aspects of registrational strategies, interactions, and filings.
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Contribute to global regulatory filings and health authority interactions.
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Serve as Medical lead on clinical programs and represent Clinical Development on program teams.
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Partner with Drug Safety to assess the safety profile of compounds.
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Write or partner in the authoring of medical aspects of core study and regulatory documents.
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Contribute to the development and review of scientific publications.
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Present at scientific, medical, and regulatory meetings.
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Maintain a high level of clinical and scientific expertise.
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Participate in due diligence or other business development activities.
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Hire, develop, and mentor a high functioning team of medical directors and clinical scientists.
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Establish, develop, and maintain relationships across Erasca.
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Perform all duties in keeping with the Companyβs core values, policies and all applicable regulations.
Benefits
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Paid Time Off, Holiday, and Sick Leave
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Medical, Dental and Vision Plans
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Short- and Long-Term Disability
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Basic and Voluntary Life/AD&D Coverage
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Flexible Spending Accounts (FSA, HSA, and Commute)
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Critical Illness and Accident Coverage
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Pet Insurance
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Employee Assistance Program
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401(k) Plan with Erasca contribution
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Opportunity to participate in an Employee Stock Purchase Program