Jobs · Information Technology · California

SVP Late Clinical Development

Erasca, Inc. · San Diego, CA · 1 mo ago
HybridInformation Technology$400k–$465k/yrFull-time

About the role

Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for cancer. The SVP Late Clinical Development will provide medical leadership and oversight of late-stage clinical trials and collaborate with the Chief Medical Officer across the Erasca portfolio.

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.
  • Lead late clinical development function, directly and through reports.
  • 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.
  • 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.

Requirements

  • 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, 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.

Qualifications

  • Must have a current license to practice medicine in the United States.

Skills

  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects simultaneously.
  • Strong organizational and time management skills.
  • Ability to work independently and as part of a team.
  • Ability to travel up to 25%.

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
  • Employee Stock Purchase Program

Pay

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, etcetera. 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.

Schedule

Full-time, Monday through Friday, 8:00 AM to 5:00 PM.

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