Associate Director, Clinical Pharmacology
Core
Leads trial-level clinical pharmacology activities, driving implementation and execution of PK/PD studies and model-based analyses to inform drug development decisions.
Role type
Senior IC Associate Director, Clinical Pharmacology
Builds
Drug development strategies and clinical study plans for small molecule and biologic compounds
Domain
Pharmaceutical industry, Clinical Pharmacology and Pharmacometrics
Deliverable
production ML models
Required skills
PK/PD principles, Model-Informed Drug Development (MIDD), study design, data analysis and interpretation, regulatory submission support, cross-functional collaboration, mentorship
Preferred skills
Programming (NONMEM, R, WinNonlin, SAS, Splus), quantitative data analysis, POP PK/PD, data visualization
Technologies
NONMEM, R, WinNonlin, SAS, Splus
Responsibilities
Lead design of Clinical Pharmacology Studies, manage data analysis and reporting, provide input to Phase 2/3 study design and registrational strategy, serve as subject matter expert for health authorities, supervise colleagues, mentor staff
Seniority
Senior, hands-on IC with mentorship responsibilities