Director, Clinical Pharmacology, Modeling and Simulation
Core
Lead the development and implementation of Clinical Pharmacology, Modeling & Simulation strategies for Amgen's pipeline of innovative therapeutic modalities to ensure optimal drug development and safe dosing regimens.
Role type
Director, Clinical Pharmacology, Modeling & Simulation (Strategy & Leadership)
Builds
Clinical development plans, regulatory filings, and product labels for new drugs across Oncology, Inflammation, General Medicine, and Rare Disease.
Domain
Biopharmaceuticals / Clinical Pharmacology / Model-Informed Drug Development (MIDD)
Deliverable
production ML models
Required skills
Strategic clinical pharmacology planning, Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, Quantitative Systems Pharmacology (QSP), regulatory document authoring, global health authority interaction, leadership of cross-functional teams, study design for special populations.
Preferred skills
PhD in Pharmacokinetics/Pharmaceutical Sciences/Pharmacology, 8+ years industry experience, bioequivalence/bio-comparability study design, pediatric study design, ADME study design, Model Based Drug Development expertise.
Technologies
Population PK/PD software, PBPK modeling software, QSP modeling tools
Responsibilities
Design strategic clinical pharmacology and modeling plans integrated with clinical development; apply MIDD strategies to guide drug development; represent the department in global cross-functional teams; author regulatory documents for global health authorities; lead the design and implementation of clinical pharmacology and biopharmaceutic studies.
Seniority
Director, strategic leadership with hands-on technical expertise