Director, Center for Drug Evaluation and Research (CDER)

Job Description

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.

Major Duties:
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.

Job Requirements

Qualifications:
I. MANDATORY QUALIFICATIONS:

A. Mandatory Educational Qualifications:
This position has an education requirement; therefore applicants must meet the requirements described below. Applicants must meet the requirements for either the Medical Officer (602) or a scientific/medical occupational series, such as Biologist/Microbiologist (401/403), Pharmacologist (405), Toxicologist (415), Veterinary Medical Officer (701), Physicist (1310), Chemist (1320), etc. These occupational series are defined by the U.S. Office of Personnel Management Qualification Standards Manual for General Schedule Positions which is available at: http://www.opm.gov/qualifications/SEC-IV/A/GS-PROF.asp.

An M.D. and/or a Ph.D. degree in a biological, medical, veterinary, or physical science, or in pharmacology.

In addition to the educational requirements, the applicant must demonstrate a high degree of scientific knowledge, executive leadership, and managerial ability.

B. Mandatory Professional/Technical Qualifications:
Please provide a written narrative describing your experience that has equipped you with the following qualifications. Please address each item separately.

1. Extensive scientific or medical knowledge applicable to the discovery, development, production, assessment, outcomes evaluation, utilization and regulation of human drugs; and

2. Executive level experience planning, directing, and evaluating scientific or medical programs and activities that demonstrates the ability to develop and implement organizational vision, mission, goals, and change, and to effectively manage a large complex organization or a multi-disciplinary scientific, technical, health related organization or academic institution; and

3. National or international recognition for individual research or clinical contributions in the fields of medicine, clinical pharmacology, or drug safety; and

4. Demonstrated experience in the recruitment, development, motivation, and retention of a diverse workforce of medical/scientific personnel, including experience communicating effectively and ensuring an understanding of the basis of decisions; and

5. Demonstrated openness to scientific dissent and diversity of thought; and

6. Demonstrated ability to build international or national coalitions that promote effective cooperation.

II. DESIRABLE QUALIFICATIONS:

1. Knowledge and understanding of the provisions, limitations, and practical application of Food and Drug Administration laws and regulations.

2. Leadership position in professional society or association and/or appointment to national or international advisory boards