Senior Director, Pharmacometrics
Core
Provide strategic and scientific leadership for pharmacometric activities supporting clinical development, using quantitative approaches to inform dose selection, trial design, and regulatory strategy.
Role type
Senior Director, Pharmacometrics (Strategic & Hands-on IC)
Builds
Model-informed drug development strategies, clinical trial designs, and regulatory submission components
Domain
Biotechnology / Pharmacometrics / Model-Informed Drug Development
Deliverable
production ML models
Required skills
Pharmacometrics, Population Pharmacokinetics (PopPK), PK/PD modeling, Exposure-response analysis, Disease progression modeling, Regulatory strategy, Clinical trial design, Benefit-risk assessment, Cross-functional leadership, Vendor/CRO oversight, Mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and lead pharmacometrics strategies across clinical development programs; Lead population pharmacokinetic (PopPK), PK/PD, exposure-response, and disease progression modeling activities; Provide quantitative input into clinical development plans, protocols, and regulatory strategies; Support regulatory submissions including INDs, NDAs/BLAs; Integrate clinical pharmacology, biomarker, efficacy, and safety data into modeling strategies; Partner cross-functionally with Clinical Pharmacology, Biostatistics, Regulatory Affairs, and other teams; Provide scientific oversight of external pharmacometrics consultants, CROs, and vendors; Advance functional capabilities, processes, and best practices; Mentor colleagues and build internal pharmacometrics capabilities.
Seniority
Senior Director, Strategic Leadership & Hands-on Technical Depth