Director, Clinical Pharmacology

Erasca•San Diego, CA

4h•$205,000 - $315,000

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: The Clinical Pharmacology Lead is responsible for providing clinical pharmacology expertise to the cross functional product development team and contributing to clinical development through advancing MIDD (Model Informed Drug Development) initiatives. The core job responsibilities include analysis, interpretation and reporting of clinical PK and PK/PD data, preparation and review clinical pharmacology data for regulatory submissions. This position also covers the DMPK Lead role through collaboration with research team on non-clinical DMPK, and translational pharmacology activities.

Requirements

PhD or PharmD with training in relevant fields such as pharmaceutical sciences, clinical pharmacology, or engineering, with a minimum of 6 years of relevant working experience (for the Director level position).
Solid knowledge and experience in pharmacokinetics, pharmacodynamics, and drug metabolism.
Proficient in using WinNonlin, NONMEM, R, and other modeling and simulation software.
Working experience in preclinical and clinical development of investigational drugs in diverse platforms including small molecules and biologics.
Proven track record in authoring DMPK and Clinical Pharmacology components of regulatory documents.
Excellent collaboration, communication, and interpersonal skills.
Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic, team-oriented environment.

Responsibilities

Provide clinical pharmacology expertise to the cross functional product development team.
Conduct data analyses including non-compartmental PK analyses, pop PK, and ER analyses.
Design and execute clinical pharmacology studies (eg, food effect, DDI, AME/Mass Balance studies).
Co-author regulatory documents such as protocol, study report, healthy authority briefing book, and IB.
Collaborate with research team on non-clinical DMPK and translational pharmacology activities.
Manage external CROs to ensure compliance with planned study protocols, deliverables, internal quality control standards, and timelines.
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.