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Opportunity: Associate Director, Clinical Pharmacology CV/MET (#1100870) @ Bristol-Myers Squibb--Princeton, NJ (US)
Submitted by Jody Aikawa; posted on Friday, March 18, 2011
RESPONSIBILITIES
In this role, the individual will have the responsibility to lead the clinical pharmacology development of Cardiovascular/Metabolic Diseases programs in full development and life cycle management, and to contribute to the design, planning, execution and interpretation of studies conducted in early clinical (Phases I and II) development. This individual will manage the clinical pharmacology profiling for cardiovascular/metabolic diseases drugs, including drug interaction, age and gender, renal and hepatic impairment, food effect, and Absorption Distribution Metabolism and Excretion studies.
The individual will be responsible for the creation and design of the Clinical Pharmacology and Pharmacometrics plan in full development and life cycle management and contribute to the Clinical Pharmacology and Pharmacometrics aspects in early clinical development. The individual will be responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and be responsible for responding to regulatory authority questions, in person and in written form. The individual will represent the department at the development matrix team level to ensure integration of the Clinical Pharmacology expertise and needs within the global development plan
REQUIREMENTS
- Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship.
- A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology is required.
- Experience in being a Study Director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting of results for multiple studies of different types for multiple projects in the Cardiovascular or Metabolic Disease areas is required.
- Must have experience developing at least one or more clinical pharmacology plans.
- Demonstrated experience in preparing regulatory submissions, including full NDAs or significant sNDAs, as well as multiple INDs.
- Experience responding to regulatory questions related to pharmacokinetics and pharmacodynamics.
- Application and knowledge of current practices and issues in the following areas for multiple projects clinical pharmacology, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and toxicology.
- Knowledge of modeling and simulation techniques, specialized software such as Gastroplus or Simcyp, and related data interpretation on multiple projects is desirable.
- Experience in pediatrics, pediatric pharmacology, or pediatric clinical trials is desirable.
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