Associate Director, Clinical Pharmacology/Senior Clinical Pharmacologist
Core
Conceive, execute, and manage multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions.
Role type
Senior IC Clinical Pharmacologist / Associate Director
Builds
Clinical pharmacology strategies, PK/PD study proposals, regulatory documents, and scientific publications for drug development.
Domain
Biopharmaceuticals / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD study design, Pharmacometrics, Drug metabolism/Transporters, Regulatory document authoring, Cross-functional team leadership, Scientific publication authoring, KOL interaction, Due diligence assessments
Preferred skills
PBPK modeling, Systems pharmacology, Exposure-response analysis, Population PK analysis
Technologies
CTDs, Investigator brochures, White papers, Journal club platforms
Responsibilities
Lead Clinical Pharmacology/PK/PD aspects of multiple projects; Design Phase 1-4 studies and clinical pharmacology strategy; Author regulatory documents including protocols, study reports, and label sections; Lead clinical pharmacology and biopharmaceutics meetings; Represent Clinical Pharmacology at regulatory meetings and cross-functional teams; Conduct due diligence assessments for business development; Author scientific publications and present at conferences.
Seniority
Senior, hands-on IC with strategic oversight