Director, Clinical Pharmacology

Role: Lead clinical pharmacology and pharmacometrics strategy for rare disease and oncology programs, focusing on accelerating product development through innovative modeling and regulatory engagement. Responsibilities: design and advise on clinical study protocols (Phases 1-3), author pharmacology sections of regulatory documents (INDs, NDAs, IBs), interface with cross-functional teams (translational science, preclinical, clinical), and perform modeling/simulation to support dose and safety decisions. Requirements: Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or related field, or MD with clinical pharmacology fellowship; 5-9+ years in biotech/pharma drug development; proficiency with WinNonlin, Monolix, NONMEM, R; experience with PK/PD modeling, regulatory interactions, and clinical study design. Preferred: oncology experience. HighValue: clinical pharmacology leadership, regulatory submissions, modeling expertise, oncology/rare disease focus, Phase 1-3 development, cross-functional collaboration. Work setup: remote or on-site with regular visits, based in Salt Lake City or NYC preferred.