Tech Stack

Description

You will provide strategic insight and technical leadership in clinical pharmacology for early-stage oncology drug development, author regulatory documents, and engage with cross-functional teams to support clinical programs targeting RAS-addicted cancers.

Requirements

• Ph.D. or Pharm.D with fellowship and 5+ years experience in Clinical Pharmacology
• Prior experience with small molecule oncology drug development
• Familiarity with FDA's Project Optimus guidance
• Hands-on experience with WinNonlin and clinical pharmacology study designs
• Strong understanding of DMPK, CMC, and Toxicology regulatory guidance

Responsibilities

• Provide strategic insight and technical leadership within Clinical Pharmacology
• Author regulatory documents (IND, EOP1, EOP2 briefing documents)
• Participate in regulatory interactions and respond to regulatory questions
• Apply quantitative modeling (PK/PD, population PK, exposure-response) to guide RP2D selection
• Design and report clinical pharmacology studies (hADME, Food-Effect, DDI)