Director, Clinical Pharmacology
Core
Lead global clinical pharmacology and pharmacometrics strategy for plasma-derived therapies treating rare and complex immunologic/hematologic 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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, PK/PD modeling, regulatory interaction management, study design, budget management, vendor management
Preferred skills
Experience with plasma-derived therapies, NonMEM/Phoenix NLME proficiency
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 documents and resolve agency queries; Manage outsourcing activities and budgets.
Seniority
Director, strategic leadership & cross-functional management
