Our mission at Erasca is embedded in our name: To erase cancer.
SVP Late Clinical Development
Location
United States
Posted
11 days ago
Salary
$400K - $465K / year
Seniority
Mid Level
No structured requirement data.
Job Description
SVP Late Clinical Development
Erasca, Inc.
Role Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit 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. A key area of focus will be the design and execution of multiple registration enabling trials in solid tumor indications. - Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of late-stage clinical programs. - 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 - 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. Qualifications - 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. - 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. - Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. - Strong learning orientation, curiosity, and commitment to science and patients. Requirements - The anticipated salary range for this position is $400,000 to $465,000. - The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. - In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Benefits - 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 - Opportunity to participate in an Employee Stock Purchase Program Company Description 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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