Associate Director, Clinical Pharmacology

1w1 week ago

Revolution Medicines

Redwood City, US · Full-time · $186,000 – $233,000

About this role

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The R&D pipeline includes RAS(ON) inhibitors like daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127 in clinical development. Join a team committed to patients with cancers harboring RAS pathway mutations.

Seeking a passionate Clinical Pharmacologist with strong early development background for the Nonclinical Development and Clinical Pharmacology Organization. Provide strategic insight and technical leadership in Clinical Pharmacology. Author reports and regulatory documents for IND, EOP1, and EOP2 milestones.

Apply quantitative modeling including translational PK/PD, population PK, and exposure-response analyses to guide RP2D selection. Collaborate with Discovery on IND-enabling assets, DMPK, and Toxicology for human dose and DDI assessments. Design FIH studies with Clinical Development and oversee hADME, Food-Effect, and DDI studies.

Engage CROs on clinical pharmacology activities and represent the function in project teams. Build cross-functional relationships to impact decisions. Thrive in a dynamic, fast-paced environment with outstanding professionals.

Requirements

Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 5+ years of relevant experience in Clinical Pharmacology
Prior experience with small molecules oncology drug development
Familiar with FDA’s Project Optimus guidance
Well-informed in current and emerging standards of regulatory requirements for clinical pharmacology
Hands-on experience with WinNonlin and Clin Pharm study designs
Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance
Excellent verbal and written communication skills to convey complex concepts
Prior management experience

Responsibilities

Provide strategic insight and technical leadership within the Clinical Pharmacology function
Author technical reports and/or regulatory documents for IND, EOP1 & EOP2 Briefing Documents and participate in regulatory interactions
Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide RP2Ds selection
Work with the Discovery organization to support IND-enabling assets, including collaboration with DMPK and Toxicology
Work with the Clinical Development team in designing FIH study
Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies
Engage and work with CROs on clinical pharmacology activities
Represent the Clinical Pharmacology function in project teams and build cross-functional relationships