Senior Director, Clinical Pharmacology
The Senior Director of Clinical Pharmacology will serve as the Clinical Pharmacology representative on project teams, providing strategic leadership and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships for the purpose of optimizing drug regimens. By integrating PK, PD, pharmacogentic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans.
- Prepare clinical pharmacology development strategies for multiple small molecule compounds.
- Design clinical pharmacology studies that yield high value PK/PD insight. Analyze PK/PD data and interpret results to maximally impact program goals.
- Drive translational approaches via the clinical development plan from phase 0 to IV. Work closely with Research and Clinical Development to fully leverage and integrate the understanding of a compound and its biology. Provide expertise and knowledge of translational aspects, including clinical biomarkers and modeling and simulation efforts.
- Develop scientific rationale and concepts for personalized/stratified medicine to optimize patient outcomes.
- Apply strong knowledge of best regulatory practices, technology and development precedent.
- Support regulatory strategy and is responsible for clinical pharmacology sections of regulatory documents.
- Has extensive knowledge and practical understanding of current clinical pharmacology within the realm of translational medicine and general drug development.
- Understands and is able to apply appropriate regulatory and ICH guidelines in the design and execution of clinical pharmacology and clinical development plans.
- Experience with immunology drug development is highly desirable.
- Possess strong leadership and excellent communication skills. An ability to manage, mentor and develop direct reports would be an asset.
Experience: At least 10 years of direct industry experience in clinical pharmacology.
Education: Ph.D., Pharm.D. or M.D. in pharmacokinetics, pharmacometrics, clinical pharmacology or related fields.