Visiting Scientist

Description:

This position is located in the Division of Biochemical Toxicology, Office of Research, National Center for Toxicological Research (NCTR), U.S. Food and Drug Administration (FDA). The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

NCTR is a multi-disciplinary research center. NCTR’s primary mission is to conduct peer-reviewed research and develop new scientific tools for the FDA to improve public health. This research produces new data and innovative tools to solve complex health issues and anticipated toxicological problems, thus enhancing FDA regulatory decision making. NCTR provides multidisciplinary training and fosters national and international collaborations with scientists from government, academia, and industry.

The Division of Biochemical Toxicology is responsible for planning and directing research specifically designed to define the biological mechanisms of action underlying the toxicity of products either regulated by, or interest to, the product centers of the Food and Drug Administration. The research is firmly rooted in mechanistic studies focused on the understanding of toxicological endpoints, an approach that allows greater confidence in the subsequent carcinogenic and reproductive toxicology risk assessments. Research within the Division capitalizes on scientific knowledge in the areas of biochemistry, organic chemistry, analytical chemistry, cellular and molecular biology, nutritional biochemistry, toxicology, and pharmacology.

Duties/Responsibilities:

NCTR is seeking a highly qualified scientist who will be a member of a multi-disciplinary team to conduct comprehensive reviews and laboratory research in support of the FDA mission.

Specific duties include, but are not limited to, the following:

• Conducts comprehensive reviews of the published literature on active ingredients in over-the-counter (OTC) drug products specified by FDA’s Division of Nonprescription Drug Products (DNDP), Center for Drug Evaluation and Research (CDER).

• Develops literature search strategies using specialized and interdisciplinary literature databases and applies scientific expertise to select articles on the safety and effectiveness of active ingredients of OTC drug products.

• Critically reviews the validity and outcome of new pharmacology and toxicology data submitted to the DNDP and summarizes the key findings and identifies any study limitations and data gaps within the scientific information.

• Conducts laboratory research at NCTR to define the biological mechanisms of action underlying the toxicities of these ingredients and/or other products regulated by the FDA.

• Perform experiments in an independent manner and collect and analyze raw data.

• Develop novel approaches, determine new research areas that need investigation, and prepare concept papers and protocols for new research projects.

• Write, edit, and publish the research results in peer-reviewed scientific journals.

• Present the results at regional, national, and /or international meetings, and scientific seminars, as well as maintain current awareness of new and emerging technologies / scientific break throughs.

• Works effectively in a multi-disciplinary team of regulatory scientists and research scientists to enhance FDA’s regulation.