Associate Director, Clinical Pharmacology
Core
Leads trial-level clinical pharmacology activities, driving implementation and execution of PK/PD principles and model-based analyses to inform drug development decisions.
Role type
Senior IC clinical pharmacology lead (Associate Director)
Builds
Clinical pharmacology and pharmacometrics plans, study designs, and data analysis for drug development
Domain
Pharmaceutical drug development, Clinical Pharmacology, Pharmacometrics
Required skills
Clinical Pharmacology, Pharmacometrics, PK/PD principles, Model-Informed Drug Development (MIDD), Drug development process, Small molecule/biologic characterization, Cross-functional collaboration, Regulatory submissions, Health authority interactions, 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 Clinical Pharmacology subject matter expert, supervise colleagues, participate in departmental and external initiatives
Seniority
Senior, hands-on IC with mentorship responsibilities