This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), in White Oak, MD.
Note: Salary figures shown represent the OPM General Schedule Base Salary. Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary.
This job is open to the following levels:
- Public (U.S. Citizens and Nationals)
- Career transition (CTAP, ICTAP, RPL)
View the full announcement and apply for this position here: https://www.usajobs.gov/GetJob/ViewDetails/603157500
The Food and Drug Administration (FDA) 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.
Do you want to join an organization that truly makes a difference? Be part of the development of cutting-edge technology? Do you want to stand at the forefront of an agency that manages the clinical trials of preventative vaccines, including the Covid-19 vaccine? If so, join CBER, a cutting-edge agency whose mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, and/or injuries. As part of our mission, we also seek to protect the public against the threats of emerging infectious diseases and bioterrorism. The Office of Tissues and Advanced Therapies (OTAT) does this by ensuring the safety, potency, effectiveness of a variety of products, including purified and recombinant therapeutic proteins for hematology, cellular therapies, gene therapies, and tissue products for the prevention, diagnosis, and treatment of human disease.
This program oversees and provides guidance on product development programs through all phases of product development for products under the program’s jurisdiction. The program decisions impact FDA and CBER’s mission to protect and advance public health. We are looking for a candidate who would be responsible for managing and directing a professional regulatory review program, a major activity of the regulatory review Office/Division.
- Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent
- A current, active, full, and unrestricted license or registration as a Physician
- Graduate training (1-year internship, residency, and fellowship)
- Must have one year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training.
- Must have five years of graduate training in hematology
- Board certification in Hematology/Oncology preferred
- 25% – Provide secondary reviews (and infrequently primary reviews) of study results or other information to determine the adequacy of clinical post-marketing requirements and commitments.
- 25% – Serve as DCEPT branch spokesperson and recognized source of information on matters related to the development of new regulations and guidance documents pertinent to cell and gene therapy, plasma protein therapeutics and other OTAT regulated medical products.
- 25% – Work directly as a committee member or chairperson to analyze and determine the adequacy of data and tests submitted by a manufacturer regarding the safety and efficacy of cellular and gene therapy products, plasma protein therapeutics, OTAT regulated decides and other biologics.
- 25% – Serve as an authoritative scientific expert (who can be sought out by peers) with respect to issues related to product manufacturing, characterization, specification, and safety testing, as well as adequacy of design, implementation, and analysis of clinical trials.
- Perform other duties as assigned.
- The position requires up to 25% travel
- The incumbent will serve as a source of continuous knowledge following marketing approval processes and perform regularly reviews the of labeling adequacy.
- Provides secondary reviews (and infrequently primary reviews) of the results of studies or other information to determine the adequacy of clinical post- marketing requirements and commitments.
- Evaluates proposed trial(s) to determine the risks and potential benefits. Will identify and analyze areas in need of new policy formation
- Reviews the protocol designs for the ability to test specific clinical hypotheses established for particular studies and to produce data that is useful to determine its safety and effectiveness.
- Consults with colleagues, other scientists, advisory committees, etc., regarding regulatory activities or other projects.
- The incumbent will serve as a principal advisor of information on matters related to the development of new regulations and provide guidance material pertinent to cell and gene therapy, plasma protein therapeutics and other regulated medical products.
- Leads, reviews, and evaluates work of subordinates related to regulatory, scientific, and clinical matters.
Working at the FDA
Working at FDA means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, FDA employees tackle unprecedented challenges to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe and reduce harm from all regulated tobacco products. We believe in collaboration, mutual respect, open communication, and opportunity for growth. If you are seeking to make a difference in the world, visit Jobs and Training at FDA | FDA to find your next career.
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate.