Division Director - Silver Spring, United States - FDA

FDA
FDA
Verified Company
Silver Spring, United States

4 weeks ago

Mark Lane

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Mark Lane

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Description
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Title 21 Vacancy Announcement_
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Department of Health and Human Services (HHS)_
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Food and Drug Administration (FDA)_
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Center for Biologics Evaluation and Research (CBER)_
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Office of Blood Research and Review (OBRR)_
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Division of Blood Components and Devices (DBCD)_


Application Period:
May 22, June 22, 2024


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 Director


Series: 0602 (Physician)


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


Work Schedule:
Full Time


Telework Eligible Yes - as determined by agency policy


Salary:
Starting at $210,000 and is set to commensurate with education and experience.


Travel Requirements: 25% or less


Cures Band(s):Band F


Full Performance Band Level:
Band F


Bargaining Unit: 8888


Note:
Incentives may be authorized; however, this is contingent upon funds availability.

If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years.


Note:
This statement does not imply nor guarantee an incentive will be offered and paid


Incentives include the following:

moving expenses, recruitment, or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.


Introduction


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 Office of Blood Review and Research (OBRR) plans and conducts research related to the development, manufacture, testing and activities of biological blood products, including those related to AIDS and those prepared by genetic engineering and synthetic procedures, in order to develop and maintain a scientific base for establishing standards designed to ensure the continued safety, purity, potency and effectiveness of biological blood products.


Duties/Responsibilities

  • Specifically, the Division Director will:_
  • Develops and maintains missionrelated, scientific programs to evaluate factors affecting the safety and effectiveness of whole blood and blood components, apheresisderived blood components, and plasma expanders, such as albumin, high molecular weight dextran's, and hydroxyethyl starches.
  • Evaluate and recommend appropriate action on 510(k) automated blood collection devices, and 510(k) Blood Establishment Computer Systems (BECS) used in the manufacture of blood and blood components.
  • Cooperate with the Office of Therapeutic Products (OTP) in the regulatory review and management of matters related to Banked Human Tissues.
  • Review clinical trial design for IND and IDE studies proposed by industry for Division regulated products and reviews subsequent data received through BLA, Biologics License Supplements (BLS), or device marketing submissions.
  • Work with other Agency components and outside organizations on a variety of issues related to these products.

Supervisory Responsibilities:


The Division Director manages a multi-disciplinary program, providing leadership and management oversight to 55 subordinate staff, including a Deputy Director, Branch and Lab.

The incumbent provides technical, clinical, and administrative leadership and direction to the subordinate staff of the Division through subordinate supervisors and exercises the full range of first and second-level supervisory responsibilities.

Plans, assigns, oversees, and directs the work to be accomplished, ensuring timely performance of a satisfactory amount and quality of work; sets and adjusts priorities and timeframes for completion of the work; provides advice and guidance to staff members; reviews work products and accepts, amends or rejects work; develops performance standards and serves as rating official on employee evalu
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