Associate Director, Pharmacometrics Lead
Core
Leads integrated pharmacometric strategy and Model-Informed Drug Development (MIDD) for multiple drug development projects from early stages through life-cycle management.
Role type
Senior IC pharmacometric lead (Associate Director)
Builds
Drug development programs and regulatory submission documents
Domain
Biopharmaceuticals / Quantitative Sciences
Deliverable
production ML models | product features
Required skills
Pharmacometrics, mechanistic modelling, statistics, regulatory guidance for pharmacometrics, PK/PD analysis, advanced modeling and simulation (QSP, MBMA, CTS), R, NonMem, STAN, SAS, Phoenix
Preferred skills
Out-sourced work oversight, scientific publications, business development due diligence
Technologies
R, NonMem, STAN, SAS, Phoenix
Responsibilities
Lead pharmacometric strategy for multiple projects, formulate and deliver pharmacometrics component of QP Plan, represent Pharmacometrics in regulatory agency meetings, oversee PK/PD and pharmacometric analyses, mentor junior staff, contribute to infrastructure and best practice initiatives
Seniority
Senior, hands-on IC with strategic independence
