Clinical Pharmacology Director
Core
Provide scientific, strategic, and operational leadership in clinical pharmacology and pharmacometrics to inform development and regulatory decisions across the product lifecycle.
Role type
Director, Clinical Pharmacology (Strategic IC)
Builds
Clinical pharmacology studies, quantitative analyses, and regulatory deliverables for oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS programs.
Domain
Pharmaceutical/Biotechnology, Clinical Development, Pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, Phase 1 study planning and execution, PK/PD modeling, population modeling and simulation, regulatory interaction support, scientific writing, vendor management
Preferred skills
None stated
Technologies
Phoenix WinNonlin, advanced pharmacometrics tools
Responsibilities
Integrate clinical pharmacology strategy within overall clinical development plans; Lead Phase 1 and special population clinical pharmacology studies; Drive PK, PK/PD, exposure–response, and biomarker quantitative strategy; Provide clinical pharmacology content for key program documents; Lead clinical pharmacology deliverables for regulatory interactions; Support post-approval commitments and lifecycle management; Provide clinical pharmacology input to due diligence and business development activities; Represent the company externally through publications and presentations.
Seniority
Director, strategic leadership with potential future people management
