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
Builds
Integrated development strategies and robust CP&P plans for small molecule and biologic drugs
Domain
Pharmaceutical drug development (small molecule and biologic)
Required skills
PK/PD principles, model-informed drug development (MIDD), clinical study design, data analysis and interpretation, regulatory submission support, stakeholder management, mentorship, cross-functional collaboration
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, manage data analysis and reporting, collaborate on regulatory submissions, participate in interactions with health authorities, work with Business Development teams
Seniority
Director, strategic leadership with hands-on technical expertise