Associate Director, Clinical Pharmacology
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 pharmacology lead (PK/PD)
Builds
Clinical pharmacology and biopharmaceutics strategies, study designs, and regulatory documents for Phase 1-4 studies
Domain
Biopharmaceuticals / Clinical Pharmacology / Pharmacometrics
Required skills
Clinical pharmacology strategy, PK/PD study design, regulatory document authoring, data analysis and interpretation, team leadership, scientific publication, due diligence, regulatory meeting representation
Preferred skills
Experience with PBPK, systems pharmacology, drug metabolism/transporters, KOL interaction, cross-functional alignment
Technologies
CTDs, investigator brochures, white papers, population PK reports, exposure-response analyses
Responsibilities
Accountable for Phase 1-4 studies design and clinical pharmacology strategy; Execute strategy and lead teams in data analysis and interpretation; Author regulatory documents including protocols, study reports, and label sections; Lead clinical pharmacology meetings and serve as representative on Clinical Strategy Team; Drive small teams to provide a unified clinical pharmacology position; Author scientific publications and present at conferences; Conduct due diligence assessments; Represent Clinical Pharmacology at regulatory meetings
Seniority
Senior, hands-on IC with strategic oversight