Director, Clinical Pharmacology
Core
Provide strategic and scientific leadership for clinical pharmacology across all stages of drug development, optimizing programs from First-in-Human through registration and life-cycle management.
Role type
Director, Clinical Pharmacology (Strategic IC)
Builds
Integrated clinical pharmacology strategies, dose selection plans, and regulatory submissions for novel therapeutics targeting metabolic dysfunction-associated steatohepatitis (MASH).
Domain
Biopharmaceuticals / Clinical Pharmacology / MASH / Metabolic Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, pharmacokinetics (PK), pharmacodynamics (PD), exposure-response analysis, dose selection and optimization, model-informed drug development (MIDD), regulatory submission preparation, bioanalytical planning, study design and interpretation
Preferred skills
Quantitative pharmacology, PBPK modeling, QSP, MBMA, experience with small molecule, siRNA, and biologic drugs, knowledge of MASH and metabolic diseases
Technologies
NONMEM, R, MATLAB, Monolix, Simcyp, GastroPlus, Phoenix WinNonlin
Responsibilities
Develop and execute integrated Clinical Pharmacology strategies spanning First-in-Human through post-marketing; Lead dose selection, dose optimization, and dosing recommendations; Design, oversee, and interpret Phase 1 and dedicated Clinical Pharmacology studies; Provide critical expertise to Business Development teams; Represent Clinical Pharmacology in governance meetings and regulatory engagement
Seniority
Director, strategic leadership with hands-on technical execution
