3h ago

Director, Clinical Pharmacology

Remote (United States)
full-timedirector Remotebiotechnology

Tech Stack

Description

As Director of Clinical Pharmacology at Revolution Medicines, you will provide strategic and technical leadership in early drug development, applying quantitative modeling to guide dose selection and pivotal study design. You will author regulatory documents, interact with the FDA, and collaborate across discovery, clinical, and CRO teams to advance novel RAS-targeted oncology therapies.

Requirements

  • Ph.D. or Pharm.D with 8+ years industry experience in Clinical Pharmacology
  • Prior experience in small molecule oncology drug development
  • Hands-on experience with WinNonlin and clinical pharmacology study designs
  • Strong understanding of DMPK, CMC, Toxicology, and related regulatory guidance
  • Prior management experience

Responsibilities

  • Provide strategic insight and technical leadership within Clinical Pharmacology function
  • Author IND, EOP1, EOP2 briefing documents and regulatory responses
  • Apply translational PK/PD, population PK, and exposure-response analyses for RP2D selection
  • Design and report clinical pharmacology studies (hADME, food-effect, DDI)
  • Represent Clinical Pharmacology on project teams and build cross-functional relationships
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