This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The Office of the Commissioner is responsible for the efficient and effective implementation of the Food and Drug Administration mission. As the Senior Clinical Advisor for Chronic Disease, the incumbent provides advice to the Commissioner and performs substantive work that cuts across major Agency-wide programs and activities.
• Offers concrete technical suggestions for stimulating further product development, in coordination with FDA medical product centers and programs.
• Produces recommendations for the Commissioner and Sr. Leadership, and drafts externally facing communications to address identified gaps such as action plans, guidances, or other communications as appropriate.
• Consults outside experts in the clinical and patient communities, as well as outside industry, as part of the initial landscape analysis on barriers to product development.
• Briefs steering committees or stakeholder groups, obtains feedback, and incorporates suggestions into work products as necessary.
• Work products will provide a roadmap for FDA staff and outside SMEs to follow, will facilitate project management that is linked to known milestones and will result in actionable products to advance an optimal regulatory approach for facilitating the development of medical products to address common chronic diseases.
To be placed into a Cures position, candidates must meet the following criteria:
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
0601 Series Requirement: Bachelor’s or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
0602 Series Requirement: 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.
Desired Education for 0602 Series: A strong candidate will have completed a residency in internal medicine as well as fellowship in relevant specialty; the incumbent will also have experience in clinical trial conduct and oversight, medical products regulation and/or biopharma product development. OR A strong candidate might alternatively have a PhD or ScD in a scientific health field with demonstrated experience in clinical trial conduct and oversight, medical products regulation and/or biopharma product development. Doctorate degree in a scientific field related to medicine, public health, pharmacology, and health sciences.
Professional Experience: The incumbent in this position will need experience developing a regulatory approach and framework to facilitate the development of medical products to address the leading common chronic diseases; and conducting comprehensive landscape analysis and assessment to include existing therapeutic options, key gaps or deficiencies, pipeline products and current risk-benefit approaches applied by reviewers.
Desired Professional Experience: Our ideal candidate will possess experience participating in and contributing to top level Office, Center, Agency, PHS and Department discussions, meetings and conferences related to common chronic disease policies, programs, projects, and legislative initiatives.