Director, Clinical Pharmacology
Core
Lead global clinical pharmacology and pharmacometrics strategy for plasma-derived therapies for rare and complex diseases.
Role type
Director, Clinical Pharmacology (Strategic IC)
Builds
Clinical pharmacology programs, regulatory submissions, and PK/PD analyses for plasma-derived products.
Domain
Pharmaceutical R&D, Plasma-derived therapies, Rare diseases
Required skills
Clinical pharmacology strategy, Pharmacometrics, PK/PD analysis, Regulatory interactions, Study design, Budget management
Preferred skills
Plasma-derived therapies experience, NonMEM/Phoenix NLME expertise
Technologies
NonMEM, Phoenix NLME
Responsibilities
Design clinical pharmacology programs for development and registration; Lead study design and execution of PK/PD studies; Contribute to regulatory submissions and resolve agency queries; Manage outsourcing activities and budgets.
Seniority
Director, Strategic leadership