Associate Director for Controlled Substances
The Food and Drug Administration (FDA) is the scientific, regulatory and consumer protection agency responsible for protecting the public health by helping to assure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, products that emit radiation, and by regulating the manufacture, marketing and distribution of tobacco products. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods, as applicable, more effective, safer, and of higher quality; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health. In addition to protecting the health of millions of American consumers, FDA’s activities have a direct impact on multi-billion dollar industries throughout the global economy. FDA regulates products that amount to 25 cents of every dollar spent. Currently, the FDA is searching for an
Associate Director for Controlled Substances
The Food and Drug Administration (FDA) is seeking an Associate Director for Controlled Substances. This position is in the Department of Health and Human Services (HHS), FDA Center for Drug Evaluation and Research (CDER), Immediate Office of the CDER Director (IO). CDER is responsible for regulating prescription drugs, including generic drugs and over-the-counter drugs. The mission of CDER is to ensure that safe and effective drugs are available to the American people, and to ensure the public health mission is supported through scientific assessment of drugs for abuse and dependence potential and scientifically-based policy recommendations.
Oversees all CDER activities related to both domestic and international drug scheduling and drug control, drug abuse liability assessment, and drug abuse and addiction. In this role, he/she makes recommendations to CDER/FDA leadership regarding scheduling of licit and illicit drugs. Leads and supervises the Controlled Substance Staff (CSS), which includes a staff of scientists, physicians, and program managers, that performs scientific and administrative functions under the Controlled Substances Act (CSA) related to drug scheduling recommendations by the HHS to the Drug Enforcement Administration (DEA). In this capacity, the incumbent will work with the Director of the CSS, who will serve as the manager for the CSS. This staff, under his/her leadership, is the technical authority on all scientific decisions and judgments in connection with the abuse potential on central nervous system (CNS) active (psychotropic) drugs for CDER and FDA. In this role, he/she is responsible for developing and maintaining the necessary skilled scientific staff within CDER to carry out this function. Provides scientific and policy leadership and guidance within CDER for activities related to interventions which may be used in FDA’s public health response to the abuse of controlled substances. This includes work to prevent the abuse of these substances through effective risk management (e.g., scheduling of a drug) as well as identifying and implementing strategies to intervene in the current public health crisis related to the abuse of controlled substances (e.g., opioids). Provides leadership within CDER in designing and implementing policies and procedures to address existing and future public health emergencies regarding drug scheduling or the misuse or abuse of the drug. Serves as the FDA and CDER liaison for collaborations with other government agencies including the DEA, Office of National Drug Control Policy (ONDCP), the Substance Abuse and Mental Health Services Administration (SAMSHA), the National Institute of Drug Abuse (NIDA), the Centers for Disease Control and Prevention (CDC), and the Department of State regarding matters of drug scheduling and the identification of new trends in, and risks related to, abuse and dependence. Provides expertise on the CSA as it relates to the work of the FDA, including drug scheduling based on scientific and regulatory assessments, to other parts of CDER/FDA as well as to HHS. Develops policies and programs involving complex and high priority scientific matters affecting the regulation of controlled substances. Directs, drafts, and reviews documents on policy proposals and regulatory decisions on these products. In the role of developing policies and programs in this area, is aware of, and continuously appraises Center-wide ongoing drug product policies and in the review and analysis of program reports, proposals, memoranda, and other materials that affect the Center’s operations and activities related to controlled substances. This individual will work with other offices in CDER and FDA, and partner agencies to develop strategies that can address the ongoing public health problem related to opioid abuse. From an overall perspective with regard to CDER management of policies related to controlled substances, participates in and contributes to top level Center, Agency, or Department discussions, meetings, and conferences on broad policy matters and issues. Monitors, coordinates, and advises FDA/CDER on new or revised policy involving sensitive, controversial, and critical problems and complex issues related to major Center activities that may involve precedent-setting matters or concern problems or issues of particular concern to the FDA/CDER or the FDA Commissioner. Represents FDA at conferences and professional meetings in the U.S. and overseas, and interacts with regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies. This is to communicate current policy developments at the Agency and to exchange information with various stakeholders. Handles highly complex assignments of national scope and significance, ensuring that regulations and policies developed are consistent with the statutory requirements and existing policy and that adequate scientific and medical reviews have been completed.
CONTROLS OVER THE POSITION (SUPERVISORY)
The incumbent of this position is directly responsible to, and functions under the administrative direction of the Deputy Center Director and Center Director.
Candidates must meet education requirements in a scientific discipline directly related to the position being filled, ideally addiction medicine, in accordance with the Office of Personnel Management (OPM) qualification standards. At a minimum, the candidate must possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D. The incumbent must meet the basic requirements for one of the occupational series listed below:
- Degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
- Degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
- Must have mastery knowledge of one or more professional fields (e.g. pharmacology, chemistry) and skill sufficient to identify and understand the most difficult, complex, and broad agency regulations and provide executive leadership and guidance in an area that has major impact on public health.
- Possesses an understanding of the principles, theories, and practices of the drug review process and policies and a working knowledge of food and drug law and regulations, including the CSA, international drug control treaties, enabling the incumbent to serve as an authority on policy, legal, and regulatory matters, consistent with the mission of the CSS.
- Possesses the needed communications skills, both written and speaking, to interact effectively with internal FDA groups, including the Commissioner, and external parties including the press, other HHS and US governmental Agencies, advocacy organizations, patient groups, and other scientific professionals.
Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Public Financial Disclosure Report (OGE 278) and will require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made.
Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required at a later time. Applicants also are advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website: http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm
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