General Summary:
- The Senior Director, Clinical Pharmacology will serve as a Disease Area leader for Clinical Pharmacology, managing the scientific functions and coordinating Clinical Pharmacology activities with other Disease Area leaders to shape innovative and integrated clinical development plans. Directs Clinical Pharmacology efforts for small molecule, large molecule, and novel modality programs (e.g., gene editing, gene therapy, cell therapy).
Key Duties And Responsibilities:
- Define the scientific direction and direct execution of clinical pharmacology plans for Disease Area programs.
- Provide strategic operational leadership to the Clinical Pharmacology function with other Disease Area Leaders.
- Manage a group of Clinical Pharmacologists (Director-level and below) to set strategy and develop/execute Clinical Pharmacology plans and studies.
- Direct Clinical Pharmacology efforts across modalities in the Disease Area.
- People management; may include financial accountabilities and human resource responsibilities.
Knowledge And Skills:
- Experience designing clinical pharmacology and pharmacometrics components of filing packages and associated clinical studies.
- Regulatory agency interaction experience, including written responses and IND packages.
- Experience with End of Phase 2 and NDA/MAA regulatory.
- Support drug development programs across all phases, including lifecycle management.
- Experience leading cross-functional teams.
- Superior communication skills; solve complex problems in a matrix environment.
- Academic/clinical postdoctoral training with significant publication history.
Education And Experience:
- Ph.D. or Pharm D (or equivalent) in pharmacokinetics, pharmacometrics, clinical pharmacology, or translational development, plus 15+ years relevant post-doctoral experience; or
- Masterβs (or equivalent) in relevant field plus 20+ years relevant experience; or
- Typically requires 5 years supervisory/management experience.