Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Core
Lead strategic, scientific, and operational aspects of multiple drug development projects from first-in-human dosing through life-cycle management, integrating PK/PD/efficacy/safety data to optimize dosing and enable Model-Informed Drug Development (MIDD).
Role type
Senior IC quantitative clinical pharmacologist (Associate Director)
Builds
Clinical pharmacology strategies, regulatory submission documents, and MIDD models for global program teams
Domain
Biopharmaceutical R&D, clinical pharmacology, pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, PK/PD analysis, MIDD, regulatory guidance (FDA/EMA/ICH), cross-functional collaboration, scientific leadership, publication/presentation
Preferred skills
Digital health integration, outcomes research, advanced modeling (QSP/MBMA), business development due diligence
Technologies
QSP, MBMA, M&S tools
Responsibilities
Lead strategic and operational aspects of multiple drug development projects; integrate PK/PD/efficacy/safety data to optimize dosing; draft and execute clinical pharmacology plans; enable MIDD practices; represent clinical pharmacology in regulatory meetings; mentor junior staff; contribute to infrastructure and best practice initiatives
Seniority
Senior, hands-on IC with strategic leadership
