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Opportunity: Director, Clinical Pharmacology (#1100796) @ 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 programs for oncology in full development and life cycle management. In addition, the invidividual will contribute to the design, planning, execution and interpretation of studies conducted in early clinical development, particularly results of human clinical trials in phases I to II of development. This individual will manage the clinical pharmacology profiling for oncology drugs with both small molecules and biologics. The individual will act as study director for the following types of clinical studies in healthy volunteers or patients: drug-drug interactions; biopharmaceutics such as BA/BE and food effect; special population studies (renal, hepatic); ADME; thorough QT; and biocomparability studies.
The individual will be responsible for the creation and design of the Clinical Pharmacology plan in full development and life cycle management and contribute to the Clinical Pharmacology aspects in early clinical development. The individual will manage the clinical study process from protocol development to final study report through regulatory dossier production, prepare protocols and conduct clinical studies of products that have been determined to satisfy a medical need and offer a commercial potential, and to serve as a clinical pharmacology expert across the organization and to government regulatory agencies. The individual will be responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and responding to regulatory authority questions. The individual will represent the department at the development matrix team level to ensure integration of the Clinical Pharmacology plan with 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 types of studies.
- Experience in Oncology is highly desirable.
- Experience with biologics is desirable.
- 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, oncology, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and toxicology.
- Knowledge of modeling and simulation techniques and related data interpretation on multiple projects is desirable.
- Proven leadership skills working in a highly matrixed organization with a successful track record as a direct supervisor, mentor and developer of people.
- Strong communication and project management skills required.
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