Division Director

Company/Institution: U.S. FDA/Center for Biologics Evaluation and Research
Location: Silver Spring, MD, USA
Degree Requirements: MD, DO, Board Eligible, Board Certified Salary: $200,000 - $249,999
Job Type: Research, Other Posted: February 13, 2023
Job Setting: Non-Profit Research Institute, Other Application Period: February 13-April 10, 2023

Title 21 Vacancy Announcement
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 Hematology (DCEH)

Application Period: 02/07/2023 – 04/10/2023

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.

Position: Division DirectorSeries: 0602 (Physician)

Location(s): White Oak Campus, Silver Spring, MD. 24145-0031.

Work Schedule: Full Time

Salary: 0602 (Physician) – Table 3: Starting at $210,000 and is set to commensurate with education and experience.

Cures Band(s): Band F

Full Performance Band Level: Band F

Travel Requirements: 25% or less

Bargaining Unit: 8888

Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
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 incumbent serves as the Director for the Division of Clinical Evaluation Hematology (DCEH) within the Office of Clinical Evaluation (OCE) under the Office of Therapeutic Products (OTP) and manages daily operations of the Division. This position reports to the Director of OCE. 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, plasma protein therapeutics, and other products regulated by OTP. The incumbent serves as Division Director, DCEH, and ensures the safety and effectiveness of biological therapies or devices regulated by OTP used in the prevention, treatment, and mitigation of disease.

The Director manages daily operations of the Division and regularly serves as a close advisor to the OCE Director and Deputy Office Director. The incumbent is responsible for fully implementing the requirements of specific Equal Employment Opportunity, Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) programs. The incumbent additionally carries out and supports other special HR programs of the Federal Government, HHS, and FDA as needed.

Specifically, the Division Director will:

  • Direct and supervise staff and oversee work focused on malignant and nonmalignant hematologic disorders.
  • Oversee policy and/or research regarding hematology-related clinical issues, such as trial design issues and safety; and oversees the development of written policies; identifies critical problems in clinical trial methodology.
  • Oversee the clinical review program in evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma-derived products and devices, for the treatment of hematologic disorders.
  • Provide guidance to sponsors regarding all phases of clinical development. Oversees the development of hematology-related clinical guidelines and procedures.

Supervisory Responsibilities:
Organizational Management: Manages a Division.
Program Management: Runs a program of singular discipline focus in the Center. Oversees or coordinates multiple functional activities.
Resource Management: Monitors and reports on resources needed to run a Division in the Center.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Identifies employee competency gaps.

Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • One year supervisory probationary period may be required.
  • Financial Disclosure may be required.
  • Ethics Clearance may be required.
  • Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.

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 Office of Talent Solutions (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.

Education Requirement:
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.

Desired Education:

Candidates would ideally have an M.D. or D.O degree, and be board-certified or board-eligible in adult or pediatric hematology.

Desired Professional Experience:

  • An experienced physician with a strong scientific background in hematology.
  • Strong leadership and skill in strategic planning, problem solving, and making policy and programmatic decisions.
  • Knowledge and experience regarding FDA scientific and review policies in the hematology area is desirable.
  • Supervisory experience is desirable.
  • Skill at building partnerships and collaborations with internal or external stakeholders.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.

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.

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

FDA is an equal opportunity employer.

About the Employer

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.

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), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OTP/OCE/DCEH Division Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through April 10, 2023.

Contact Information

CBER Human Capital
10903 New Hampshire Ave
Silver Spring, MD 20993 USA

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