- Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of the naporafenib clinical program and contribute to clinical decision making across the Erasca portfolio. Participate in building and maintaining a culture of rigorous data-driven decision making.
- 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.
- Serve as Medical lead on clinical programs and represent Clinical Development on program teams.
- Contribute to regulatory filings including authoring clinical sections for INDs, 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.
- 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.
- M.D. degree or equivalent, with subspecialty fellowship training and board certification or eligibility in Oncology or Oncology/Hematology.
- 7-10+ 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 in a dynamic biotech company required.
- Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required.
- Experience as the clinical lead on a complicated global program with multiple indications and studies preferred.
- Experience in early and late-stage drug development highly 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 passion for science and patients.
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VP Clinical Development - San Diego, United States - Erasca, Inc.
Description
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.
VP Clinical Development
Position Summary:
Reporting to the Chief Medical Officer, the VP Clinical Development will provide medical leadership and oversight of the naporafenib development program and collaborate with the CMO across the Erasca portfolio. 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. In addition, the VP will be a hands-on drug developer and will serve as clinical lead and/or medical monitor on programs or studies.
Essential Duties and Responsibilities:
Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program.
Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.
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