Director, Clinical Pharmacology
Core
Leading clinical pharmacology strategies and execution across drug development programs using PK/PD principles and model-informed approaches.
Role type
Director, Clinical Pharmacology & Pharmacometrics (IC)
Builds
Integrated development strategies, robust CP&P plans, and clinical study designs for small molecule and biologic drugs.
Domain
Pharmaceutical drug development (small molecule/biologic)
Required skills
PK/PD analysis, model-informed drug development (MIDD), study design, data interpretation, stakeholder management, mentorship, regulatory interaction, business development assessment
Preferred skills
Programming (NONMEM, R, WinNonlin, SAS, Splus), quantitative data analysis, POP PK/PD, data visualization
Technologies
NONMEM, R, WinNonlin, SAS, Splus
Responsibilities
Supervise and mentor CP&P leads, contribute to compound development, represent Clinical Pharmacology at asset teams, provide input to Phase 2/3 study design, lead design of Clinical Pharmacology studies, manage data analysis and reporting, collaborate on regulatory submissions, interact with health authorities, participate in cross-functional initiatives, assess external acquisitions
Seniority
Director, strategic leadership with hands-on technical contribution