Director, Clinical Pharmacology
Core
Leading the planning, implementation, and execution of clinical pharmacology strategies across drug development programs, applying PK/PD principles and model-informed approaches to support decision-making.
Role type
Director, Clinical Pharmacology (Strategy & Leadership)
Builds
Integrated development strategies and robust Clinical Pharmacology & Pharmacometrics (CP&P) plans aligned with compound strategy.
Domain
Pharmaceutical drug development (small molecule and/or biologic)
Required skills
PK/PD principles, model-informed drug development (MIDD), study design, data analysis and interpretation, regulatory submissions, stakeholder management, mentorship, cross-functional collaboration, health authority interactions, 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 across phases, represent Clinical Pharmacology at asset teams, provide input to Phase 2/3 study design and registrational strategy, lead design of Clinical Pharmacology studies, collaborate on cross-functional teams and regulatory submissions, participate in interactions with health authorities, lead departmental initiatives, work with Business Development teams
Seniority
Director, strategic leadership with hands-on expertise