Duties/Responsibilities

The incumbent serves as the Division Director of the Division of Human Tissue (DHT) within the Office of Cellular Therapy and Human Tissue CMC (OCTHT) under the Office of Therapeutic Products (OTP) and manages daily operations of the Division. This position reports to the Director of OCTHT. 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. DHT is responsible for the interpretation of existing regulations and guidance regarding human cells, tissues, or cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a human recipient such as bone, ligaments, tendons, heart valves, corneas, skin, oocytes, semen, and hematopoietic stem/progenitor cells derived from peripheral and cord blood. DHT is also responsible for development and implementation of new regulations and guidance regarding human cellular and tissue-based products.  The incumbent serves as Division Director, DHT, and strives to ensure the safety and integrity of these products as they relate to communicable disease risks and serves as the FDA expert on issues relating to human cellular and tissue-based products used for a variety of indications across the nation and abroad.

The Director manages daily operations of the Division and regularly serves as a close advisor to the OCTHT Director. The incumbent supervises a staff of medical officers, scientists and specialists engaged in all aspects of human cellular and tissue-based scientific and regulatory activities. 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:

• Provide scientific and technical advice and assistance within and outside the assigned organization, including interaction with other CBER offices, other centers, Office of the Commissioner (OC), Office of the Assistant Secretary of DHHS, the eye and tissue banking industry, professional organizations, and foreign governments.
• Coordinate the regulatory principles applied to blood, blood products, cells and tissues to ensure consistency, where applicable.
• Work with inter-Center groups making jurisdictional decisions about human tissues as to whether regulation should be as a human tissue, a biological product, a drug, or a medical device.
• Conduct pioneering studies of outstanding scope, difficulty, and complexity. Assignments involve assessing the limitations of proven concepts and practices in a broad and complex area where tissues and factors to be considered are largely undefined and require extensive probing and analysis to determine the nature and scope of the problems.
• Provide expertise and leadership in supervising a staff of medical officers, interdisciplinary scientists, and specialists in the implementation of regulatory programs, policies, standards, criteria, procedures and guidance applicable to human cells and tissues intended for transplantation.
• Plan, implement, coordinate, and evaluate long-range, extensive plans for regulation and guidance development relating to human cellular and tissue-based products.
• Direct special projects, studies or activities of concern to the Center Director, Office Director, and/or Super Office Director which may involve the coordinated effort of several offices, centers, various components of the OC and DHHS. Such projects may involve operational matters on cell and tissue policy and may result from a public health emergency, a congressional mandate, or a departmental mandate. The incumbent will perform such projects or activities personally or will establish and lead committees and work groups as needed.
• Serve as an advisor to managers on OCTHT, Center, and Agency-wide regulatory and policy issues concerning human cellular and tissue-based products.
• Utilize an in-depth knowledge of FDA and current technologies, particularly in the area of regulations and guidance concerning human cells and tissues.
• Exercise delegated authority to make commitments on behalf of the OCTHT Director.
• Assist the Office of Compliance and Biologics Quality (OCBQ), the Office of Regulatory Affairs (ORA), and the Office of Biological Product Operations (OBPO) on compliance issues and staff training pertaining to inspections of cell and/or tissue establishments.
• Provide authoritative guidance, advice, assistance, interpretations, and recommendations outside of the Agency to other federal agencies, such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA).
• Provide expertise in the development of CBER’s responses to inquiries such as those from the media, industry, consumers, and state or federal authorities, including the Unites States Congress.
• Represent OCTHT, OTP, CBER, and FDA in national and international forums through meetings, visits, conferences, speeches, and participation in seminars and workshops.
• Serve as the Chairperson of the Tissue Reference Group, an inter-center group which includes membership from CBER’s Office of the Director and FDA’s Office of Chief Counsel.
• Serve as the Chairperson of the Tissue Safety Team, a CBER group which includes membership from DHT, OCBQ, and the Office of Biostatistics and Pharmacovigilance (OBPV).
• Conduct or administer pioneering biological studies, investigations, or critical projects of outstanding scope, difficulty and complexity in important biological areas of national interest.

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.  

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/OTP/OCTHT/DHT Division Director”  in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through November 30, 2023.

View the full announcement here: https://www.fda.gov/media/173496/download?attachment

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.

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.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• 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.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
   1. Qualified applies to all candidates for Cures appointments. The FDA 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.
   2. 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:

• An ideal candidate would hold a BS degree in a scientific discipline

Desired Professional Experience:

• Strong leadership and skill in strategic planning, problem solving, and making policy and programmatic decisions
• Strong background in science and policy issues related to the human tissue banking industry
• Supervisory experience is desirable
• Skilled at building partnerships and collaborations with internal or external stakeholders
• Strong communication skills that include writing for publication and public speaking

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.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: 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.

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.