Deputy Director for Analgesics and Controlled Substances

3 days ago


Silver Spring, Maryland, United States AE Strategies Full time
Job Title: Deputy Director for Analgesics and Controlled SubstancesJob Summary

AE Strategies is seeking a highly qualified Deputy Director for Analgesics and Controlled Substances to join our team. As a key member of our organization, you will be responsible for coordinating and providing input on efforts and regulatory programs within the Office of New Drugs (OND) on programs directed towards analgesia drug development, controlled substances, and disorders related to their use.

Key Responsibilities
  • Serves as a liaison to CDER and FDA efforts on analgesic drug development, substance use disorders, and controlled substance programs and policies.
  • 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, substance use disorders, including on opioids, psychedelics, stimulants, alcohol, and other such disorders regulated in OND.
  • Provides leadership for policy development related to analgesic drug development, controlled substances, substance use disorders, or overdose reversal treatments in coordination with OND policy.
  • 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, substance use disorders, overdose prevention, and management.
Requirements
  • Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent from a school in the United States or Canada.
  • 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.
  • Skill in applying 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.
Working with AE Strategies

AE Strategies is a strategic recruiting partner for the Food and Drug Administration (FDA). Our role is to identify and pre-screen candidates, and then to introduce these candidates to hiring managers at the FDA. We are committed to finding the best candidates for full-time federal positions across the Agency.



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