The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs and medical devices are safe and effective, that cosmetics, foods, food additives, drugs, and medicated feeds for food-producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform 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. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
21st Century Cures Act Eligibility: This position supports the development, review, or regulation of medical products.
This position reports to: Supervisory Physician within the Clinical Divisions (below), Office of New Drugs. This position is located in Silver Spring, Maryland.
The Division of Neurology I (DNI) regulates and reviews Investigational New Drug (IND) applications and marketing applications for drug and biologic products for the treatment of neurodegenerative disorders, movement disorders, and neuromuscular disorders, such as Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, muscular dystrophy, amyotrophic lateral sclerosis, and spasticity.
The Division of Neurology II (DN II) regulates and reviews Investigational New Drug (IND) applications and marketing applications for drug and biologic products for the treatment of seizures, epilepsies, medical countermeasures, migraine, other headaches, traumatic brain injury, inner ear disorders, stroke, and neuroimmunologic disorders (e.g., Multiple Sclerosis).
Functional duties and responsibilities:
- Serve as a Physician within a clinical review division to determine whether clinical trials of new drugs in humans related to a therapeutic area are soundly conceived, and supported by prior animal testing and other controls adequate to justify tests in humans review applications by manufacturers for permission to market new drugs for general use should be approved based on an evaluation of the evidence of their safety and effectiveness; and ensure proposed labeling contains truthful claims for safety and effectiveness, and adequate directions for use and warnings against misuse.
- Review supplements and amendments to previously approved NDAs, which must be thoroughly reviewed for efficacy and safety in acting on a supplement; review periodic reports submitted by sponsors on drugs approved for marketing; review adverse reaction and other safety reports. Make medical decision in each case as to whether the indicated population of a previously approved NDA should be expanded, whether changes in the labeling reflecting new safety information is required, and whether the information submitted and otherwise available supports approval of the supplement.
- Review the summaries of pharmacologists and chemists as part of the decision-making process and determine whether or not to approve an application. Make science-based recommendations that an NDA or a supplement submission be approved, is incomplete on specific points, or not be approved such an IND be continued, modified, or placed on clinical hold.
- Assigned work in the area of medical specialty, in as much as this is practicable based on the types of applications received. Drug submissions assigned for review will include drugs whose evaluation will be challenging and complex and require mature professional judgment. Physicians within the Division are considered to be the Agency's foremost specialists in assigned therapeutic areas and indications, and in appropriate clinical trial design for evaluation of drugs intended to treat such conditions.
- Contribute on a multi-disciplinary scientific team to arrive at a conclusive medical opinion; considers a variety of types of information, such as research findings and clinical studies. Provide authoritative comments on research designs and new endpoints or clinical procedures and, in meetings with industry sponsors of an application. Prepare correspondence (e.g., information requests) requesting additional data when deficiencies or areas of unclarity can be addressed with additional information.
- Consult with other medical specialists and scientists within FDA, and other government agencies, universities, hospitals, and Clinics to address areas of uncertainty or for input on complex and challenging medical issues bearing on applications in IND development, or in areas where there is unmet medical need and regulatory policy and guidance is needed.
- Keep abreast of the progress in medical and related sciences by reviewing the scientific literature, attending conferences, and participating in staff seminars, at which, cases and special topics are discussed. As appropriate, may contribute to such scientific literature, internal and external conferences, seminars, and workshops helping to advance clinical and scientific understanding in areas of her/his expertise.
Position’s Desired Skills, Experience, or Education:
Degree: 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; Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
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, 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.
Licensure: For all band levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.