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.

Essential Duties and 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.

Required Education and Experience:

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.

The anticipated salary range for this position is $205,000 to $315,000. 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.

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.

Director, Clinical Pharmacology

TLDR