Associate Director, Pharmacometrics Lead
Core
Leads integrated pharmacometric strategy and Model-Informed Drug Development (MIDD) for multiple drug development projects from translational stages through life-cycle management.
Role type
Senior IC pharmacometric lead (Associate Director)
Builds
Pharmacometric components of Quantitative Pharmacology (QP) Plans and regulatory submission documents
Domain
Biopharmaceuticals / Pharmacometrics / Model-Informed Drug Development
Deliverable
production ML models
Required skills
Pharmacometrics, mechanistic modelling, statistics, R, NonMem, STAN, SAS, Phoenix, PK/PD analysis, regulatory guidance, dose selection
Preferred skills
QSP, MBMA, CTS, out-sourced work oversight, scientific publications, regulatory agency meetings
Technologies
R, NonMem, STAN, SAS, Phoenix
Responsibilities
Lead pharmacometric strategy for multiple projects; formulate and deliver QP Plan components; perform PK/PD and pharmacometric analyses; represent Pharmacometrics in regulatory meetings; mentor junior staff; contribute to infrastructure and best practice initiatives; publish and present at scientific societies.
Seniority
Senior, hands-on IC with strategic independence