Bristol-Myers Squibb Company

Associate Director, Clinical Pharmacology and Pharmacometrics

Location
Princeton, NJ, US
Posted
Apr 12, 2018
Ref
R1115585
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Description and Responsibilities:

This individual will apply their Clinical Pharmacology and Drug Development expertise to the development of small molecule and biologic assets that help patient prevail over serious disease conditions including immunoscience, fibrosis and cardiovascular disease.

This person will play a central role in the planning, design, execution, analysis, interpretation and reporting healthy subject and patient studies conducted in early, full and life cycle stages of development. A successful candidate will provide critical input on the design and execution of Clinical Pharmacology plans and be able to create a robust human Clinical Pharmacology profile by integrating results from a broad spectrum of non-clinical, clinical and model-based drug development assessments. The candidate will also participate in generating modeling and simulation (M&S) plans and conducting population pharmacokinetic and exposure-response analyses for the assets and manage analyses conducted by pharmacometric vendors ensuring timely delivery of pharmacometric deliverables (e.g., dataset specification documents, pharmacometric analysis plans, pharmacometric reports etc).

This individual will serve as the Clinical Pharmacology subject matter expert on cross functional asset teams and provide his/her functional expertise during health authority interactions and regulatory submissions.

Position Requirements:

The requirements for this position include Ph.D.in pharmacology or pharmaceutical sciences, or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology and Pharmacometrics is required. The person that fills this role will have experience in the hands on modeling and application of quantitative clinical pharmacology including, pharmacometrics and other model-based approaches to guide drug development (using appropriate software and techniques). Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, analysis, data interpretation and reporting is a prerequisite. Experience of working on the development of both small molecules and biologics is highly desirable. Knowledge of PBPK modeling including a working understanding of SimCyP and GastroPlus is desirable. The successful applicant should have experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). She or he will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, toxicology. Strong oral and written communication skills necessary to formally present and report information internally and externally is required. The ability to work in a dynamic team oriented environment is essential.