Sr/Exec Director Clinical Development

Erasca•San Diego, CA

3d•$265,000 - $310,000

About The Position

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. Position Summary: Reporting to the Chief Medical Officer, the Senior or Executive Director, Clinical Development will drive the clinical aspects of late-stage clinical development studies or programs. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. The Senior or Executive Director, Clinical Science will also have individual study level responsibility for one or more trials.

Requirements

Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred.
At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely related clinical development function.
Extensive experience in oncology clinical trials required; late-stage development experience required, early development experience a plus.
Experience leading clinical development contributions to regulatory submissions (e.g. (NDA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) highly preferred.
Experience in dynamic start up or small company environments required.
Demonstrated ability to contribute to strategic clinical planning and work effectively independently and on cross-functional teams.
Demonstrated ability to evaluate, interpret, and present complex scientific data.
Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles.
Excellent verbal and written communication and presentation skills.
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.
Flexibility, with the willingness and ability to manage through strategic shifts.
Strong learning orientation, curiosity, and commitment to science and patients.

Nice To Haves

early development experience a plus
Experience leading clinical development contributions to regulatory submissions (e.g. (NDA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) highly preferred.

Responsibilities

Lead in the planning and execution of clinical studies to successfully move the program through pivotal trials and eventual submission, regulatory approval, and launch.
Key clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed.
May attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions.
Represent Erasca externally at scientific meetings and congresses.
Establish and maintain strong relationships with internal teams, clinical investigators, regulatory agencies, and key stakeholders.
Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.
Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.
Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.