Director, Clinical Pharmacology

In this role, you will:
- Develop clinical pharmacology and pharmacometrics strategies to accelerate the product development plan; lead clinical pharmacology for programs and represent regulatory interactions.
- Provide clinical pharmacology input for study design across Phase 1–3 and dedicated Phase 1 studies.
- Author/lead clinical pharmacology sections for regulatory documents (e.g., IBs, INDs, NDAs) and serve as the clinical pharmacology expert with health authorities.
- Collaborate cross-functionally with clinical study, translational (DMPK, translational modeling & toxicology), preclinical, and due diligence teams.
- Oversee and/or perform modeling and simulation to solve drug development questions and expedite decisions.

Qualifications & experience:
- Ph.D. in Pharmaceutical Sciences/Pharmacokinetics (or related), M.D. with Clinical Pharmacology expertise, or Pharm.D. with Clinical Pharmacology fellowship; 5–9+ years in biotech/pharma drug development.
- Demonstrated leadership of clinical pharmacology aspects of drug development.
- Experience with PK, PK-PD, and PK-safety analyses (non-compartmental analysis, population PK, PK-PD modeling/simulation) for dose selection and exposure-response/safety.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or similar modeling tools.
- Experience responding to regulatory agency questions and preparing clinical pharmacology sections for submissions.
- Oncology experience preferred (not required).

Working location/compensation:
- SLC/NYC preferred; remote considered with regular on-site visits.
- Base salary range: $234,190–$287,980 (NYC/Boston/SF Bay Area) or $212,900–$261,800 (Salt Lake City/other US). Eligible for annual bonus, equity, and comprehensive benefits.