Director, Clinical Pharmacology

In This Role, You Will
- Develop clinical pharmacology and pharmacometrics strategies to accelerate and support the overall product development plan; act as Clinical Pharmacology lead and representative for regulatory interactions.
- Design clinical studies and provide clinical pharmacology input from Phase 1–3 and dedicated Phase 1 clinical pharmacology studies.
- Author review clinical pharmacology sections for regulatory documents (IBs, INDs, NDAs, and other submissions) and serve as the clinical pharmacology expert with health authorities.
- Interface with cross-functional teams (clinical study teams, translational teams such as DMPK and Translational Modeling & Toxicology, preclinical, and due diligence) to ensure clinical pharmacology considerations are addressed.
- Solve drug development questions through modeling and simulation to expedite decision-making.

The Experience You’ll Need
- Ph.D. in Pharmaceutical Sciences/Pharmacokinetics or related; or M.D. with Clinical Pharmacology expertise; or Pharm.D. with Clinical Pharmacology fellowship; plus 5–9+ years in biotech/pharmaceutical drug development.
- Demonstrated success leading clinical pharmacology aspects of drug development.
- Experience managing PK/PK-PD/PK-safety analyses (non-compartmental analysis, population PK, PK-PD modeling/simulations) to support dose selection and exposure-response/exposure-safety analyses.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
- Ability to drive collaboration, influence, and resolve conflicts.
- Demonstrated regulatory experience responding to agency questions, preparing submission components, and attending regulatory meetings.
- Oncology experience preferred.

Working Location & Compensation
- Based in Salt Lake City (SLC) or New York (NY) preferred; remote considered with regular on-site visits.
- Estimated annual base range: $212,900–$297,000; eligible for annual bonus, equity, and comprehensive benefits.