In This Role, You Will
- Develop clinical pharmacology & pharmacometrics strategies to accelerate the overall product development plan; serve as Clinical Pharmacology lead and regulatory interaction representative.
- Provide pharmacology input to clinical study designs (Phase 1β3 and dedicated Phase 1 clinical pharmacology studies).
- Author clinical pharmacology sections for regulatory documents (IBs, INDs, NDAs, and other submissions) and act as clinical pharmacology expert with health authorities.
- Interface with cross-functional teams (clinical, translational/DMPK & modeling/toxicology, preclinical, due diligence) to address clinical pharmacology considerations.
- Oversee and/or perform modeling and simulation to solve drug development questions and expedite decision making.
The Experience Youβll Need
- Ph.D. (Pharmaceutical Sciences/PK or related), M.D. with Clinical Pharmacology expertise, or Pharm.D. with Clinical Pharmacology fellowship; 5β9+ years in biotech/pharma drug development.
- Proven leadership in clinical pharmacology aspects; experience managing PK, PK-PD, and PK-safety analyses (non-compartmental analysis, population PK, PK-PD modeling/simulations) to support dose selection and exposure-response/exposure-safety.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
- Experience responding to regulatory questions and preparing clinical pharmacology content for submissions.
- Oncology experience preferred.
Location & Compensation
- Home base ideal: SLC or NYC; remote considered with regular on-site visits.
- Estimated base salary: $234,190β$287,980 (NYC/Boston/SF Bay Area) or $212,900β$261,800 (Salt Lake City & other U.S.); plus annual bonus, equity, and comprehensive benefits.