Senior Director, Pharmacometrics

📋 Description

• Develop and lead pharmacometrics strategies across assigned clinical development programs, aligning
• Lead population pharmacokinetic (PopPK), PK/PD, exposure-response, disease progression, and other
• Provide quantitative input into clinical development plans, protocols, statistical analysis plans
• Support regulatory submissions and interactions, including INDs, NDAs/BLAs, briefing documents
• Integrate clinical pharmacology, biomarker, efficacy, safety, and other relevant data into modeling
• Partner cross-functionally with Clinical Pharmacology, Clinical Development, Biostatistics, Data

🎯 Requirements

• PhD, PharmD, MD, or equivalent advanced degree in Pharmacometrics, Clinical Pharmacology
• Typically 12–15+ years of relevant biotechnology or pharmaceutical industry experience, including
• Demonstrated expertise in population PK (PopPK), PK/PD, exposure-response, modeling and simulation
• Experience developing quantitative strategies, independently executing or overseeing complex
• Demonstrated experience supporting regulatory submissions and preparing materials for, or
• Proficiency with commonly used pharmacometric modeling and simulation tools such as NONMEM