1d ago

Senior Director, Clinical Pharmacology

Remote (United States)

$232k-$290k / year

full-timelead Remotebiotech

๐Ÿ›  Tech Stack

๐Ÿ’ผ About This Role

You'll lead clinical pharmacology strategy for a late-stage oncology company developing novel RAS(ON) inhibitors. You'll apply quantitative modeling to guide dose selection and regulatory submissions, impacting critical decisions in early development.

๐ŸŽฏ What You'll Do

  • Provide strategic insight and technical leadership in clinical pharmacology.
  • Author regulatory documents for IND, EOP1, EOP2 milestones.
  • Design and report clinical pharmacology studies (hADME, Food-Effect, DDI).
  • Engage with CROs on clinical pharmacology activities.

๐Ÿ“‹ Requirements

  • Ph.D. or Pharm.D with 8-10 years of industry experience.
  • Experience with small molecule oncology drug development.
  • Familiarity with FDA Project Optimus guidance.
  • Hands-on experience with WinNonlin and clinical pharmacology study designs.

โœจ Nice to Have

  • Prior experience interacting with FDA on dose optimization.
  • Hands-on experience with PBPK models.

๐ŸŽ Benefits & Perks

  • ๐Ÿ’ฐ Competitive cash compensation
  • ๐Ÿ“ˆ Robust equity awards
  • ๐Ÿฅ Strong benefits
  • ๐Ÿ“š Learning and development opportunities

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter screenยท 30 min
  2. 2Hiring manager interviewยท 45 min
  3. 3Panel interviewยท 60 min
0 0 0