Director, Office of Vaccines Review and Research
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 the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy announcement here: https://www.fda.gov/media/154271/download
The mission of the Center for Biologics Evaluation and Research (CBER) mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. The Office of Vaccines Research and Review (OVRR) protects and enhances public health by assuring that available vaccines, allergenic extracts, and related products are safe and effective.
The Director reviews and evaluates the safety and efficacy of investigational new drug applications (INDs) and IND amendments for vaccines and related biological products, providing guidance and recommendations to IND sponsors with regard to the chemistry, manufacturing and control information, preclinical safety assessments and first-in-man clinical trials for these products. Regulatory actions include but are not limited to approval or disapproval of the proposed first-in-man clinical studies. Performs the investigational device exemption (IDE) review process for devices related to vaccines and related products regulated by the office.
The Director reviews and evaluates the safety and efficacy of biologic license applications and amendments submitted by manufacturers of preventive vaccines for infectious disease indications and related biological products, including labeling, and takes regulatory action accordingly. The Director plans and conducts research related to the development, manufacture, and testing of vaccines and related products, including those for pandemic influenza vaccines and those prepared by genetic engineering and synthetic procedures and all other emerging Infectious diseases, to support the regulatory process and to assist in establishing methodologies and standards to ensure the continued safety, purity, potency, and effectiveness of products regulated by this office.
Desirable Education:
- Candidates would ideally have a master’s degree, doctoral degree, or both in Biology or Microbiology, or a medical degree.
Basic Qualifications:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Application Procedures:
Submit electronic resume or curriculum vitae, SF50, and letter of interest with “CURES CBER/OVRR Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through January 15, 2022.
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.