Division Director

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

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.

The Division of Blood Components and Devices (DBCD) reviews, evaluates, and takes appropriate action on applications related to the manufacturing of blood and blood components, plasma expanders, blood collection and processing devices, blood storage solutions, and medical device applications related to immunohematology testing of blood and blood components intended for transfusion. DBCD maintains mission-related, scientific programs to evaluate factors affecting the safety and effectiveness of whole blood and blood components and develops related policies.

Duties/Responsibilities

The incumbent serves as the Division Director of the Division of Blood Components and Devices (DBCD) within the Office of Blood Review and Research (OBRR) and manages daily operations of the Division. This position reports to the Director of OBRR. The Division Director evaluates and recommends appropriate action on blood and plasma Biologics License Applications (BLAs), and related supplements, as well as BLA applications related to, plasma expanders, such as albumin, high molecular weight dextran’s, and hydroxyethyl starches.

Specifically, the Division Director will:

• Develops and maintains mission-related, scientific programs to evaluate factors affecting the safety and effectiveness of whole blood and blood components, apheresis-derived blood components, and plasma expanders, such as albumin, high molecular weight dextran’s, and hydroxyethyl starches.
• Evaluate and recommend appropriate action on medical device applications related to immunohematology testing of blood and blood components intended for transfusion or companion diagnostic indications.
• Evaluate and recommend appropriate action on new drug application and abbreviated new drug application and related to blood storage containers, anticoagulant and blood storage solutions.
• 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.
• Provide clinical, pre-clinical, and clinical pharmacology review and recommends appropriate action on BLAs, investigational new drug applications (INDs), new drug applications (NDAs), PMAs and 510(k) submissions pertinent to manufacturing of blood products within the Office’s purview.
• 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 evaluations; serves as a hiring manager or approves selection for all positions; hears and resolves group and individual grievances and serious complaints; effects various disciplinary actions; approves leave and compensatory time, awards, reassignments, and other personnel actions; promotes team building; identifies and implements ways to streamline operations and increase workload productivity.

Determines the staffing levels needed, requests the resources required and allocates personnel to adequately and effectively perform the mission of the Division. Analyzes changes and trends in workload distribution and shifts human resources commensurate with such analysis. Identifies the impact of changing mission requirements and prepares documents necessary to justify and change position authorizations. Interacts with other managers and supervisors throughout the organization to identify, coordinate and resolve issues crossing organizational lines.

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), unofficial transcripts, and letter of interest with “CURES CBER/OBRR/DBCD Division Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through July 21, 2024.

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.

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

FDA is an equal opportunity employer.