Duties

• The incumbent will serve as Supvervisory Physician (Hematology) responsible for managing and supervising staff and overseeing work focused in the Nonmalignant Hematology functional area.
• 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.

Requirements

Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• 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.
• Background Investigation Requirement: 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.
• 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.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• THIS POSITION IS SUBJECT TO THE COVID-19 VACCINE MANDATE AS A CONDITION OF EMPLOYMENT.

Qualifications

The position of Supervisory Physician (Hematology) falls under the 0602 occupational series. To qualify for this position at grade GP-15, you must meet the following:

Basic Requirements:

A. DEGREE : You must have a Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association (external link) ; Association of American Medical Colleges (external link) ; Liaison Committee on Medical Education (external link) ; Commission on Osteopathic College Accreditation of the American Osteopathic Association (external link) , or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.

OR

B. Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (external link) , a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination.

NOTE: You must provide a copy of your Doctor of Medicine transcripts (unofficial), foreign equivalency, or ECFMG results with your application to document that you have met the education requirement. Failure to do so will result in you being rated ineligible for this position. Your transcripts must show completion/conferred date. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to your starting work.

AND

LICENSURE: For all grade levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. You must provide a copy of your medical license with your application. Failure to do so will result in you being rated ineligible for this position.

AND

GRADUATE TRAINING: Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, a candidate must have had at least 1 year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Descriptions of such programs are described below.

An internship program involves broadly based clinical practice in which physicians acquire experience in treating a variety of medical problems under supervision (e.g., internal medicine, surgery, general practice, obstetrics-gynecology, and pediatrics). Such programs are in hospitals or other institutions accredited for internship training by a recognized body of the Accreditation Council for Graduate Medical Education (ACGME) (external link).

A residency program involves training in a specialized field of medicine in a hospital or an institution accredited for training in the specialty by a recognized body of the American Medical Association (external link) , (AMA) or Accreditation Council for Graduate Medical Education (ACGME) (external link).

A fellowship program involves advanced training (beyond residency training) in a given medical specialty in either a clinical or research setting in a hospital or an institution accredited in the United States for such training.

AND

ADDITIONAL TRAINING / QUALIFICATIONS: Additional requirements for GS-15 -- Applicant must have 5 years of graduate training in the specialty of the position to be filled or equivalent desired experience and training related to the treatment of hematologic disorders and/or experience in non-malignant hematology.

Preferred Board Certification in Hematology/Oncology.

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.

Vaccination Mandate :

• In accordance with Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.

Expanded/Maximum telework Posture :

• Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement within 30 calendar days of receiving notice to do so, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 12/27/2021. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. You must continue to meet all requirements through the hiring process.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date . To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login , select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Education

TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

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 employee, you are not exempt from transcript requirements.

Electronic Transcript Caution : If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

FOREIGN EDUCATION
Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.
Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

National Association of Credential Evaluation Services (NACES)

Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation

Additional information

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: Yes, Medical
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit Position: No
Telework eligible position: Telework is at the discretion of the supervisor.
• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

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 .

Additional Information:

• 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.
• Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS. ???????
• If you are serving, or have served in the last 5 years (from 12/27/2021) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.