FDA - Deputy Super Office Director Analgesics, Controlled Substances, and Substance Use Disorders - AE Strategies
Silver Spring, MD
About the Job
Description
The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to identify and pre-screen candidates, and then to introduce these candidates to hiring managers at the FDA.
Introduction
The Food and Drug Administration 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.
Introduction
The Food and Drug Administration 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.
Functional Duties and Responsibilities
The incumbent serves as the Deputy Director for Analgesics, Controlled Substances and Substance Use Disorders within the Office of New Drugs (OND). The position is responsible for coordinating, providing input, and direction on efforts and regulatory programs within OND on programs directed towards analgesia drug development, controlled substances, and disorders related to their use, including treatments for the range of substance use disorders (SUD) and development of overdose reversal agents regulated within OND. The incumbent will have direct Office-level technical authority and will coordinate and provide input across OND on all relevant programs on SUD and related reversal agents.
This incumbent will perform the following:
This incumbent will perform the following:
- Serves as a liaison to CDER and FDA efforts on analgesic drug development, substance use disorders and controlled substance programs and policies, as well as serving as a key OND representative to external groups (e.g., patient stakeholders, academic groups, other governmental organizations, industry) that are engaged in development of treatments for pain, for SUD, and policy development regarding controlled substances
- Under the direction of the Office Director, coordinates and provides office-level guidance to OND office and divisional leadership on development programs focused on controlled substances and analgesic drug development
- Leads policy development and associated guidance development for analgesics, SUDs including on opioids, psychedelics, stimulants, alcohol, and other such disorders regulated in OND
- Provide leadership for policy development related to analgesic drug development, controlled substances, SUD or overdose reversal treatments in coordination with OND policy
- Provides OND office-level coordination and technical direction of IND development programs as well as NDA/BLAs targeting analgesic drug development, SUD and overdose reversal for programs regulated by OND
- Coordinates activities with the Office of the Center Director (OCD), Controlled Substance Staff (CSS) on development of policy, research efforts, and other such activities related to analgesic drug development, controlled substances, SUD, overdose prevention and management
- Serves as the OND representative on the Real World Evidence (RWE) subcommittee for research/studies focused on controlled substances, SUD treatment, and overdose prevention and management
- Serves as the point person to assure OND delivery of relevant agency priorities on controlled substances in conjunction with CSS and CDER staff.
- Represents OND in CDER or FDA working groups focused on analgesic drug development, controlled substances, SUDs, and overdose prevention and management with other OND SMEs as appropriate
- Acts as liaison with other government agency groups involved in policy development on analgesic drug development, controlled substances, SUD, and overdose reversal such as working with National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Drug Abuse (NIDA), Department of Defense (DoD) and other relevant organizations
- Coordinates OND research efforts focused on analgesic drug development, controlled substances, SUD or OD reversal agents
- Works with OND offices and divisions to coordinate and support advisory committees and other external meetings on analgesic drugs, controlled substances, SUD, or overdose prevention or management (e.g., workshops, symposia) to assure high quality and productive meetings
- Coordinates with legislative affairs (Office of Legislation in CDER) to respond to inquiries on activities for analgesics, controlled substances, SUD and overdose prevention and management
Desired Education, Skills, or Experience
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.
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.
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.
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.
Specialized Experience
Skill in applying their clinical and scientific expertise to complex multifaceted medical problems such as in benefit/risk determinations. Understanding of advanced professional theories, principles, concepts, standards, and methods sufficient to conceive and apply to unique circumstances and develop an understanding of these new circumstances, and determine appropriate actions.
Skill in applying their clinical and scientific expertise to complex multifaceted medical problems such as in benefit/risk determinations. Understanding of advanced professional theories, principles, concepts, standards, and methods sufficient to conceive and apply to unique circumstances and develop an understanding of these new circumstances, and determine appropriate actions.
Ability to resolve unique or novel problems and conditions, thereby addressing complex and challenging problems in the context of regulatory review of medical products.
Knowledge of clinical, medical, and scientific literature and current clinical activities relating to new drugs and biologics in the assigned therapeutic area.
Source : AE Strategies
