Director, Clinical Pharmacology

Role: Lead Clinical Pharmacologist providing strategic and scientific oversight across all stages of drug development for metabolic disease therapeutics, specifically MASH. Responsibilities: develop integrated clinical pharmacology strategies from First-in-Human through post-marketing, guide dose selection, characterize pharmacokinetics and pharmacodynamics, assess drug-drug interactions, and support regulatory submissions. Collaborate with cross-functional teams including Clinical Development, Translational Medicine, Biostatistics, and Regulatory Affairs; contribute scientific content to INDs, NDAs, and post-marketing commitments; and drive model-informed drug development approaches. Requirements: Ph.D. or PharmD in pharmacology, biomedical engineering, or related field; 12-15 years of industry experience in pharmacology, including small molecules, biologics, or biomarker development; expertise in pharmacokinetics, exposure-response modeling, DDI, and regulatory guidance (FDA, EMA, ICH). Preferred qualifications include experience in early and late-stage development, regulatory submissions, and familiarity with metabolic diseases or MASH. HighValue: focus on metabolic dysfunction-associated steatohepatitis (MASH), Phase 3 outcomes trial, experience with model-informed drug development tools (PopPK/PD, PBPK, QSP), and contributions to scientific publications. WorkSetup: not specified, but likely hybrid or onsite based on seniority and collaboration needs.