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Branch Chief

Employer
Center for Biologics Evaluation and Research, FDA
Location
Silver Spring, Maryland
Salary
Starting at $180,000 and is set to commensurate with education and experience.
Closing date
Jun 20, 2022
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Title 21 Cures Announcement

Center for Biologics Evaluation and Research (CBER)

OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT)

DIVISION OF CLINICAL EVALUATION AND PHARMACOLOGY/TOXICOLOGY (DCEPT)

__________________________________________________________________

Position:  Branch Chief*

*Multiple selections will be made from this announcement (Malignant Hematology Branch Chief and Nonmalignant Hematology Branch Chief)

Series: This position may be filled with the following series: Physician (602)

Location(s): Silver Spring, Maryland

Area of Consideration: Open to the Public

Travel Requirements: 25% or less

Cures Band: D                      

Full Performance Band Level: D

Cures Position Type: Supervisory Physician

Salary: Starting at $180,000 and is set to commensurate with education and experience.

Conditions of Employment: United States Citizenship or U.S. National.

Special Notes: This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate/s selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority.

Additional information on 21st Century Cures Act can be found here.

Introduction:

The Food and Drug Administration (FDA) 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) 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. 

The Office of Tissues and Advanced Therapies (OTAT) plans and conducts research related to the development, manufacture, and testing of cellular, gene therapy (including those utilizing naturally occurring viral vectors and those prepared by genetic engineering and synthetic procedures), therapeutic vaccines, and plasma-derived and coagulation products in order to develop and maintain a scientific base for establishing standards for safety, purity, potency, and effectiveness.

The Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) develops and maintains the Office’s Clinical, Clinical Pharmacology, and Pharmacology/Toxicology Review Programs. Provides clinical, clinical pharmacology and non-clinical review and recommends appropriate action on Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Investigational Device Exemptions (IDEs), Pre-Market Approval Applications (PMAs), and 510(k) submissions pertinent to products within the Office’s purview. Provides recommendations on clinical, clinical pharmacology, and non-clinical programs intended to support IND, BLA, NDA, IDE, PMA, and 510(k) submissions.

Position Summary:

The Branch Chief guides the clinical review program which include 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. Provides guidance to sponsors regarding all phases of clinical development. Develops clinical guidelines and procedures, Federal register statements, and special projects. Determines the appropriateness of the design with respect to the objectives of the study and the development of the drugs or devices; assures that reviews are completed on time, that potential benefits are weighed against reasonably foreseeable risks to human subjects; and provides guidance to sponsors in answering questions central to drug development in a timely and safe manner.

Duties/Responsibilities:

Specifically, the Branch Chief:

  • The incumbent will serve as Supervisory Physician (Hematology) responsible for managing and supervising staff and overseeing work focused on hematologic conditions. Depending on the branch, responsibilities will include oversight of either malignant hematologic disorders or nonmalignant hematologic disorders.
  • Develops policy and/or research regarding hematology related clinical issues, such as trial design issues and safety. Oversees the development of written policies, identifies critical problems in clinical trial methodology.
  • Directs 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.
  • Provides guidance to sponsors regarding all phases of clinical development. Engages in developing hematology related clinical guidelines and procedures.
  • Determines the appropriateness of the design with respect to the objectives of the study and the development of the drugs or devices.
  • Supervises the review and evaluation of clinical data submitted in marketing applications. Evaluates reports of clinical trials in humans for evidence of safety and effectiveness.

Supervisory Responsibilities:

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.

Professional Experience/Desirable Qualifications:

5 years of graduate training in the specialty of the position to be filled or equivalent desired experience and Board Eligible/Board Certified in pediatric or adult hematology with experience/expertise in either malignant or nonmalignant hematologic conditions.

Basic Qualifications:

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

Conditions of Employment:

  • One-year probationary period may be required.
  • Background and/or Security investigation required.
  • U.S. citizenship is required.
  • All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
  • This position may be subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee.  For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Application Procedures:

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 active medical license, copy of your transcripts (unofficial), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OTAT/DCEPT Branch Chiefsin the subject line to: CBERHumanCapital@fda.hhs.gov.

Equal Employment Opportunity Policy

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 Policy

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.

 

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

FDA is an equal opportunity employer.

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