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RESPONSIBILITIES

In this role, the individual will have the responsibility to lead the clinical pharmacology development of neuroscience programs in full development and life cycle management, and to 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 neuroscience drugs, including drug interaction, age and gender, renal and hepatic impairment, food effect, and absorption distribution metabolic excretion studies in healthy volunteers as well as contribute to the design, planning, execution and interpretation of studies conducted in early clinical development.

The candidate will be responsible for the creation and design of the clinical pharmacology plan in full development and contribute to the clinical pharmacology aspects of the clinical plan in early clinical development. The individual will oversee and manage the clinical study process from protocol development to final study report through regulatory dossier production, preparation of protocols and conduct of clinical studies for products that have been determined to satisfy a medical need and offer a commercial potential.

The candidate will also serve as a clinical pharmacology expert to peers and direct reports, across the organization and to government regulatory agencies. The candidate will be responsible for and oversee the preparation of the clinical pharmacology components of regulatory submissions and responses 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 of direct pharmaceutical 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 of results for multiple projects as well as experience developing clinical pharmacology plans is needed.
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 in 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, mentor and developer of people.

PREFERENCES

Direct experience working in the neurosciences therapeutic area, including the development of drugs for affective disorders, pain and/or cognitive disorders, is preferred.
Knowledge of and hands on experience with modeling and simulation techniques and related data interpretation is highly desired.

LOCALE: Trenton, NJ

HOW TO APPLY

To apply for this position please copy and paste the following URL into your browser: http://ars2.equest.com/?response_id=22bb93f62522804192229fcbd87d5dc9

Discussion forums: Opportunity: Associate Director, Clinical Pharmacology Neuroscience (#1000421) @ Bristol-Myers Squibb--Trenton, NJ (US)

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