This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 3, Band F (GS-15 equivalent).
In order to qualify for the Division Director position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/12/2025: Basic Qualification Requirements: A. DEGREE: You must have a Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association (external link); Association of American Medical Colleges (external link); Liaison Committee on Medical Education (external link); Commission on Osteopathic College Accreditation of the American Osteopathic Association (external link), or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. OR B. Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (external link), a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination. AND Graduate Training: Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, a candidate must have had at least 1 year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Descriptions of such programs are described below. An internship program involves broadly based clinical practice in which physicians acquire experience in treating a variety of medical problems under supervision (e.g., internal medicine, surgery, general practice, obstetrics-gynecology, and pediatrics). Such programs are in hospitals or other institutions accredited for internship training by a recognized body of the Accreditation Council for Graduate Medical Education (ACGME) (external link). A residency program involves training in a specialized field of medicine in a hospital or an institution accredited for training in the specialty by a recognized body of the American Medical Association (external link), (AMA) or Accreditation Council for Graduate Medical Education (ACGME) (external link). A fellowship program involves advanced training (beyond residency training) in a given medical specialty in either a clinical or research setting in a hospital or an institution accredited in the United States for such training. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. RELEVANT YEARS OF EXPERIENCE: In the addition to the above qualifications, applicants must meet the following relevant years of experience combinations to qualify for this AD-0602 Band F (GS-15 equivalent) position. At least 4 years of relevant experience such as developing and evaluating methodologies for an assigned therapeutic drug area within a division; collaborating with other division leadership to develop policies and procedures in support of the drug application review process; evaluating drug applications for safety and effectiveness and formulates decisions or recommendations regarding approvability; ensuring the multi-discipline scientific reviews teams decision adheres to internal review guidance and policies.
Provides leadership and direction to subordinate supervisors and staff who review and evaluate New Drug applications (NDAs), Investigational New Drug (INDs) and Biologics License Applications (BLAs ), to determine drug safety and effectiveness. Participates with other division leaders on original research projects on the review and regulation of medical products and determines whether the protocols for study of such drugs relate to the establishment of evidence to evaluate safety. Advises the Office Director in matters related to employee resources to support drug application review, strategic planning and implementation of activities affecting policies, programs and goals on safety and effectiveness of human drug products. Ensures the division's overall daily operations are effective and efficient, carries out the mission of the office, and provides leadership, program direction, and general supervision over daily administrative and scientific operations activities. Serves as chair for industry meetings and has designated signature authority on non-NME, NDAs, supplements, IND protocol reviews managed by the division. Provide supervisory review of scientific reviews, presentations, general advice letters other information request correspondence prepared by subordinate staff for correctness of medical facts and conformance to existing policy. Represents FDA on committees or at meetings of scientific and professional groups with both national and international groups and organizations outside the government and with industry. Provides occupational specific technical and administrative direction and supervision to subordinate supervisors and staff performing the work and functions of the organizational unit.