PharmExec Blog

FDA Launches Search for CDER Director

FDA has launched a nationwide search for Director, Center for Drug Evaluation and Research (CDER). The open period for applications continues through Friday, February 1, 2008. The detailed job announcement and instructions for applying are available on the USAJOBS site. See Job Announcement Number FDA-AD-2008-01.

About FDA and CDER
The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, a significant portion of our nation’s food supply, cosmetics, and products that emit radiation. We are also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered “drugs.”

The largest of FDA’s five centers, CDER has about 2,200 employees. Approximately half of the staff is made up of physicians or other kinds of scientists, including chemists, biostatisticians, and epidemiologists.

For more information about the Center for Drug Evaluation and Research, please see the CDER Overview.

Job Summary
The CDER Director will have the unique opportunity to help define drug regulatory policy for the next generation. With increased resources and user-fee funding, the Director will lead CDER in the expedited review of applications for new drug products; work to make innovative, new medical treatments available to the patients with greater assurance of safety, effectiveness, and quality; reduce the time to conduct reviews on generic drug applications; conduct post-market surveillance and regulation throughout the product’s lifecycle; improve communication with and education of consumers and healthcare professionals through more accurate and timely information about drug products and potential hazards; and enforce and ensure compliance to guarantee that companies market only the highest possible quality products.

This leadership position also has a critical role in supporting the development, availability, maintenance and deployment of medical countermeasures to biological, chemical, and radiological/nuclear threats and incidents, in the event of natural disaster, terrorist events, or other emergencies.

Candidates must clearly show that they possess the experience, knowledge, skills and ability to perform the duties of this executive position. Typically, experience of this nature will have been gained at or above the GS-15 grade level in the Federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.

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