Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Office of Clinical Evaluation (OCE)
Division of Clinical Evaluation Oncology (DCEO)
Oncology Branch 2 (OB2)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Salary: 0602 (Physician) = Table 3: Starting at $180,000 and is set to commensurate with education and experience
Cures Band(s): Band D
Telework Eligible: Yes - as determined by the agency policy
Full Performance Band Level: Band D
Travel Requirements: 25% or less
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.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that 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’s 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. CBER protects and advances the public health by ensuring that biological products are safe, 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.
The incumbent serves as the Branch Chief for the Oncology Branch 2 (OB2) within the Division of Clinical Evaluation Oncology (DCEO) and the Office of Clinical Evaluation (OCE) under the Office of Therapeutic Products (OTP) and manages daily operations of the Branch. This position reports to the Director of DCEO. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies and other products regulated by OTP. The Branch evaluates the design and the results of all oncology clinical trials with investigational biologic agents and devices that have been submitted to OCE and is charged with providing guidance to sponsors during the process of drug development, assuring consistency in the evaluation process, and establishing guidelines in the clinical methodology.
Specifically, the Branch Chief will:
Direct the clinical review program in the evaluation of clinical data and protocols related to biological products, particularly in cell and gene therapies, plasma- derived products and devices, for the treatment of oncological disorders.
Provide guidance to sponsors related to all phases of clinical development.
Develop clinical guidelines and procedures, Federal register statements, and special projects.
Determine suitability of the clinical trial design with respect to the objectives of the study and the development of the drugs or devices.
Supervise the review and evaluation of clinical data submitted in marketing applications.
Evaluate the reports of clinical trials in humans for evidence of safety and effectiveness.
Provide guidance to sponsors in responses essential to the drug development in a timely and safe manner.
Manage and supervise the Branch staff and oversee work pertaining to oncological conditions.
Develop policy and/or research regarding oncology-related clinical issues, such as trial design issues and safety.
Oversee the development of written policies and identify critical problems in clinical trial methodology.
Engage in the development of oncology-related clinical guidelines and procedures.
Mentor and promote the professional development of members of the Branch.
Organizational Management: Manages a Branch.
Program Management: Runs multiple projects. Identifies best uses of available resources to achieve tasks.
Identifies projects needed to achieve activities.
Resource Management: Determines best use of resources to achieve tasks. Identifies resource needs for multiple projects.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Conducts or arranges actions to meet employee competency goals; identifies personnel in need of competencies
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.
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Candidates would ideally have an M.D. or D.O. degree and be board-certified or board-eligible in adult or pediatric oncology.
Desired Professional Experience:
Clinical experience in adult or pediatric oncology
Experience in clinical trial design, analysis, and/or regulation.
Ability to prioritize and make critical decisions.
Developing short- and long-term programmatic goals.
Work collaboratively with a diverse cadre of customers and stakeholders.
Knowledge and understanding of current FDA regulations, policies, and procedures pertaining to safe and effective drugs and biologics.
Experience monitoring trials of investigational agents for safety.
How to Apply
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP/OCE/DCEO/OB2 Branch Chief” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through July 6, 2023.
For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
View full vacancy announcement here: https://www.fda.gov/media/167088/download
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer.