GENERAL SUMMARY:

The Senior Director, Clinical Pharmacology will serve as a Disease Area leader for Clinical Pharmacology. The Senior Director, Clinical Pharmacology will also manage the scientific functions and coordinate the activities of the Clinical Pharmacology function in collaboration with the other Disease Area leaders. The role’s responsibilities will include maintaining organizational processes across the group, influencing clinical program strategy, and integrating activities with other departments across the Global Research and Development organization, to help shape innovative and integrated clinical development plans. As a Disease Area leader, the Senior Director, Clinical Pharmacology will also direct Clinical Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell therapy, in the Disease Area.

KNOWLEDGE AND SKILLS:

• Experience designing clinical pharmacology and pharmacometrics components of filing packages and associated clinical studies
• Experience with regulatory agency interactions including written responses and IND packages
• Experience with Early Development Phase, as well as End of Phase 2 and NDA/MAA regulatory
• Support of drug development programs in all Phases including life-cycle management
• Different therapeutic modality experience (large molecule, small molecule, etc.)
• Experience leading cross-functional teams
• Superior communication skills
• Ability to solve complex problems while working in a matrix environment
• Academic or clinical postdoctoral training with significant publication history

EDUCATION AND EXPERIENCE:

• Ph.D. or Pharm D (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 15+ years of relevant post-doctoral employment experience, or
• Masters Degree (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 20+ years of relevant employment experience, or
• Typically requires 5 years of supervisory/management experience
  

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• Defines the scientific direction and directs the execution of clinical pharmacology plans for Disease Area programs
• Provides strategic operational leadership to the Clinical Pharmacology function in collaboration with the other Disease Area Leaders
• Manages a group of Clinical Pharmacologists at Director-level and below to set strategy, develop and execute Clinical Pharmacology plans and studies for Disease Area programs
• Directs Clinical Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell therapy, in the Disease Area.
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.