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Director, Clinical Pharmacology and Pharmacometrics

Employer
Bristol Myers Squibb Company
Location
Princeton, NJ, United States
Start date
Feb 25, 2019

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Job Details

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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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