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/Pharmacometrics)
Builds
Clinical pharmacology strategies, PK/PD study proposals, regulatory documents, and scientific publications for immunology, oncology, and neuroscience products.
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, Business development due diligence
Preferred skills
Strategic thinking, Enterprise view, Original idea generation, Cross-functional alignment
Technologies
PK/PD modeling tools, PBPK, CTDs, Investigator Brochures
Responsibilities
Design Phase 1-4 studies and clinical pharmacology strategy; Lead teams in data analysis and interpretation of model results; Author regulatory documents including protocols, study reports, and label sections; Present at Clinical Strategy Team meetings and cross-functional teams; Represent Clinical Pharmacology at regulatory meetings and business development teams.
Seniority
Senior, hands-on IC with leadership responsibilities