DIRECTOR (Clinical Pharmacology/Virology)(Job Number: 1201588)
- The selected candidate will serve multiple roles: as an individual contributor to projects, pharmacometrics expert and manager of scientists. As an individual contributor, the candidate will lead the clinical pharmacology and pharmacometrics development of virology programs in exploratory and full development.
- This will include program level clinical pharmacology plan development and execution, as well as associated regulatory interactions; the candidate is also responsible for study level management from protocol development to clinical study reporting.
- The candidate will also provide oversight of and manage strategic and technical aspects of pharmacometrics and exposure-response analyses to support knowledge integration and dose selection.
- In this pharmacometrics role, the candidate will be required to conduct some hands-on analyses, oversee outsourced pharmacometric analyses and oversee the technical and strategic aspects of pharmacometric plans and analyses conducted within BMS.
- The candidate will also serve as a clinical pharmacology manager, providing clinical pharmacology and pharmacometrics leadership and mentoring to a small group of scientists, and participate in resource planning and management within the clinical pharmacology and pharmacometrics group.
Job Function: Clinical Pharmacology
- 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 of direct pharmaceutical industry experience is required.
- Experience as a study director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting of results for multiple projects as well as experience developing clinical pharmacology plans is required.
- Hands-on experience with pharmacometrics techniques and related data interpretation is required. Direct experience working in the virology therapeutic area, including the development of HIV and/or HCV products, is preferred.
- The candidate must have previous experience in preparing regulatory submissions, including NDAs and INDs and responding to regulatory questions related to pharmacokinetics and pharmacodynamics. Application and knowledge of current practices and issues in the clinical pharmacology as well as in the bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and toxicology areas is expected.
- The candidate will require strong communication and leadership skills working in a highly matrixed organization, with a successful track record as a direct supervisor and/or mentor and developer of people.
Primary Location: NA-US-NJ-Hopewell
: R&D - Research
Bristol-Myers Squibb - 2 years ago
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