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Deputy Super Office Director Analgesics, Controlled Substances, and Substance Use Disorders

3 months ago

Silver Spring, United States AE Strategies on behalf of the FDA Full time
Hospital, Public and Private Academic Medical Group Advisory / Regulatory College / University Government Independent Medical / Diagnostic Laboratory Independent Medical Groups Life Science & Biopharmaceutical Companies Medical Group Medical Review Organization Private Industry Public Health Research Facility

Required Education:

Doctorate

Additional Information:

Telecommuting is allowed. Employer will assist with relocation costs.

Internal Number:

Introduction
 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. 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. The incumbent will also have a key role in supporting and leading efforts in OND for policy development (e.g., guidance development) on the treatment and management of substance use disorders,
development of medications for pain management, and reversal agents related to controlled substances.
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.

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.

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.

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. About AE Strategies on behalf of the FDA We help federal clients design, develop, and implement innovative solutions that improve organizational effectiveness, empower workforces, and maximize the use of data in decision-making.The Food and Drug Administration (FDA) has contracted AE Strategies as their strategic recruiting partner to help identify candidates for over full-time federal jobs for physicians, scientists, and senior leaders.