Bristol-Myers Squibb Company

Director, Clinical Pharmacology and Pharmacometrics

Location
Princeton, NJ, US
Posted
Nov 05, 2018
Ref
R1505361
Required Education
Doctorate/PHD/MD
Position Type
Full time
This individual will have responsibility for leading the clinical pharmacology support of BMS oncology and immuno-oncology assets. This person will play a pivotal roles in the design, planning, execution and interpretation of studies conducted in early, full and life cycle management phases of clinical development. She or he will have responsibility for the management and oversight of the clinical pharmacology profiling of small molecule and biologic oncology drugs. The individual will act as the study director on clinical pharmacology focused studies in healthy volunteers and patients, including: drug-drug interactions; biopharmaceutics; special population studies; ADME; thorough QT; and biocomparability studies. The successful applicant will be responsible for the design and implementation of the Clinical Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical study process from protocol development to final study reporting. The person filling this position will serve as the clinical pharmacology representative and subject matter expert on internal development coordinating bodies. This individual will be responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and will represent the Clinical Pharmacology line at meetings with regulatory agencies and health authorities.

The requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship. A minimum of 7+ years experience gained through direct industry experience in Clinical Pharmacology is required. Experience as a Study Director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting is a prerequisite. Experience in oncology and the development of small molecules and biologics as well as in the use of pharmacometric and model guided drug development techniques is also desirable. The successful applicant will have experience in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). This person will have experience in responding to regulatory questions related to all aspects of clinical pharmacology. This individual will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology. This individual will have strong communication and project management skills and demonstrate a successful record of leadership in a matrix organization and as a 1st line supervisor and mentor.