1d ago
Senior Director, Clinical Pharmacology
Remote (United States)
$232k-$290k / year
full-timelead Remotebiotech
๐ Tech Stack
๐ผ 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.
๐ฏ 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.
๐ 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.
โจ Nice to Have
- Prior experience interacting with FDA on dose optimization.
- Hands-on experience with PBPK models.
๐ Benefits & Perks
- ๐ฐ Competitive cash compensation
- ๐ Robust equity awards
- ๐ฅ Strong benefits
- ๐ Learning and development opportunities
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter screenยท 30 min
- 2Hiring manager interviewยท 45 min
- 3Panel interviewยท 60 min
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