Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Core
Lead strategic, scientific, and operational aspects of multiple drug development projects from first-in-human through life-cycle management, driving Model-Informed Drug Development (MIDD) and optimizing dosing.
Role type
Senior IC quantitative clinical pharmacologist (lead)
Builds
Clinical pharmacology plans, regulatory submissions, and dosing strategies for novel treatments
Domain
Biopharmaceuticals / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models
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, business development due diligence
Technologies
QSP, MBMA, advanced modeling and simulation
Responsibilities
Lead strategic and operational aspects of multiple drug development projects; Integrate PK, PD, efficacy, and safety data to optimize dosing; Draft and execute clinical pharmacology plans; Enable MIDD practices and advanced modeling; Represent Clinical Pharmacology in regulatory agency meetings; Mentor junior staff; Contribute to infrastructure and best practice initiatives
Seniority
Senior, hands-on IC with strategic leadership