Director, Office of Blood Research and Review (OBRR)
Center for Biologics Evaluation and Research, FDA
April 3, 2018
Silver Spring, Maryland
Commensurate w/ education/expe
Full Time - Experienced
The Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) is seeking qualified candidates to serve as the Director, Office of Blood Research and Review (OBRR). OBRR’s broad mission is to ensure the safety, efficacy, and availability of blood and blood-related products through regulation, research, and policy development. The multidisciplinary staff includes scientific and medical professionals engaged in a wide range of activities which include policy development for blood collection, product labeling, and application review; collaboration with other Center Offices on pre-market inspections and health hazard determinations; research on new scientific tools and procedures to enhance knowledge of blood borne diseases; and review and evaluation of investigational new drug applications (INDs), blood product license applications (BLAs), and investigational device exemptions (IDE).
The Director, OBRR is responsible for the planning, development, and administration of the Office's broad national programs and operational activities, providing leadership and technical direction in the execution of programs and the day-to-day management of OBRR activities. As such, the Director plays a key role in guarding and protecting the integrity and safety of the nation’s blood supply and sources of blood, blood factors, and blood products. He/she provides advice and counsel to the CBER Center Director, FDA Commissioner, and other high-level officials within and external to the FDA; establishes and coordinates OBRR regulatory research and review functions within the overall program objectives established by the Center, FDA, and Department of Health and Human Services (HHS); and represents the Center, FDA, and HHS on committees and professional meetings, nationally and internationally. The Director, OBRR also:
Manages and directs over 150 employees through subordinate Division Directors, making decisions and recommendations on personnel actions; resolving issues encountered by subordinate supervisors; counseling staff on administrative matters; and setting standards for and appraising work performance of staff;
Prepares and presents testimony to Congress and other outside bodies, attending and participating in Congressional hearings when appropriate on issues related to blood and blood-related products; and
Performs other related duties as assigned.
U.S. Citizenship is required; This position will require travel; Selective service registration is required for males born after 12/31/1959; A security investigation and/or 1-year supervisory probationary period may be required.
This position may be filled through Title 42(f) or Direct Hire under Title 38. Candidates should review the qualification requirements for each and submit appropriate documentation for the authority under which they wish to be considered. Candidates must meet either the minimum requirements under Title 42(f) -OR- the minimum requirements under Title 38 to be considered.
Title 42(f) Qualification Requirements: At minimum, Title 42(f) candidates must possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D. Additionally, candidates must have professional experience and stature in their area of expertise commensurate with the duties of the scientific position being filled.
Title 38 Qualification Requirements:At minimum, candidates must have a Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from an accredited school in the United States or Canada. Applicants must also possess a 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; and must possess 5 years of graduate-level training in the specialty of the position to be filled or equivalent experience and training.
In addition to either of the requirements listed above, all candidates must meet the below experience requirements:
All candidates must possess specialized knowledge and experience in the development and regulation of blood and blood-related products, including the evaluation of safety, effectiveness, and product quality; strong leadership and significant executive management experience; excellent interpersonal skills to deal effectively with multidisciplinary teams and diverse stakeholders; and outstanding oral and written communication skills. Knowledge of the FDA’s regulatory and review processes is highly preferred.
Note: Official transcripts will be required prior to appointment. Education completed in foreign colleges or universities may be used to meet qualification requirements if you can show that the foreign education is comparable to that received in an accredited educational institution in the United States. Applicants should provide evidence when applying.
This position may also be filled by appointment in the U.S. Public Health Service, Commissioned Corps.
LOCATION: This position is located in Silver Spring, Maryland. Relocation expenses and other recruitment incentives may be paid.
HOW TO APPLY: Submit electronic resume or curriculum vitae (CV) and supporting documentation to CBER Recruitment at CBER.Employment@fda.hhs.gov. Supporting documentation may include: educational transcripts, medical license, or board certifications. Applications will be accepted through May 15, 2018. Please reference Job Code: OBRR-18-0002-AABB.
NOTE: Please be advised that this position may be subject to FDA’s strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT
Additional Salary Information: Only candidates eligible for and being considered under Direct Hire through Title 38 may receive physician market pay. An excellent benefits package is available.
Internal Number: OBRR-18-0002-AABB
About Center for Biologics Evaluation and Research, FDA
The Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.