This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Specialty Medicine (OSM), Division of Imaging and Radiation Medicine (DIRM), in Silver Spring, MD.
Note: Candidates may be eligible to receive Title 38 Physician and Dentist Pay (PDP), in addition to the regular General Schedule base salary. (Salary range identified on vacancy announcement, is based on the GS pay/locality table).
Learn more about this agency
- Incumbent serves as a Lead Physician and a senior, principal advisor to the Division Director and other team members on matters relating to evaluating Investigational New Drug Application (INDs) and Biologic License Applications.
- Reviews work for completeness of scientific, clinical and medical content for Investigational New Drug Applications (INDs) for all drugs and biological products regulated by FDA.
- Leads clinical assignments related to New Drug Applications or Biologic License Applications. Serves as an authority on the clinical aspects of the drug or biologic applications in his/her therapeutic areas it relates to marketing approval.
- He/She identifies the adequate and well controlled trials and assesses the effectiveness of the drug or biologic by reviewing and/or overseeing the review of the submitted evidence and reports of such trials.
- Documents the findings with regard to efficacy and safety which culminates in a benefit-risk assessment after the evaluation.
- Serve as clinical participant for the pre-market and post-market evaluation of new drugs and biologics for safety and effectiveness and for enforcing safeguards for testing of investigational drugs and biologics in humans.
- Leads the team in identifying, distributing, and balancing workload among employees.
- Provides clinical, scientific and regulatory advice on new drugs and biological products.
25% or less – You may be expected to travel for this position.
Conditions of Employment
- Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
- 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.
- Selective Service Registration: 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.
- 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.
- Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
- 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.
- You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
- 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.
- Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
The position of Lead Physician falls within the 0602 occupational series. To qualify for this position at grade GP-15, you must meet Time-in-Grade requirements by 11:59 pm EST on 03/31/2021.
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.
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.
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.
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.
ADDITIONAL TRAINING / QUALIFICATIONS: Additional requirements for GS-15 — 5 years of graduate training in the specialty of the position to be filled or equivalent experience and training evaluating the safety and effectiveness of Investigation New Drug Applications (INDs), New Drug Applications (NDAs) and/or Biologic License Application (BLAs) as it relates to marketing approval.
Please be sure to clearly define the number of graduate training years using month and year – in addition, to describing duties performed during that time period.
Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
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.
You must submit supporting documentation to verify your eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details…
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 .
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 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.
ADDITIONAL CONDITIONS OF EMPLOYMENT:
We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
- Pre-employment physical required: No.
- Drug testing required: No.
- License required: Yes, Medical.
- Mobility agreement required: No.
- Immunization required: No.
- Bargaining Unit Position: Yes, TBD
If you are serving, or have served in the last 5 years (from 03/31/2021) 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. Political Appointees FAQ – OPM
- Financial disclosure statement, OGE-450, required: This position 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.
All requirements must be met by the closing date of this announcement (03/31/2021); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.
Additional selections may be made within the same geographical area FDA-wide.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
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.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 03/31/2021), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well-Qualified or Qualified.
Career Transition Assistance Program (CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors) for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site .
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA’s separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA’s.
To preview the application questionnaire, click the link below.
Background checks and security clearance
Drug test required
Position sensitivity and risk
Moderate Risk (MR)
Trust determination process
Credentialing , Suitability/Fitness
- Medical License
- SF-50/ Notification of Personnel Action
- Resume Writing Tutorial
- Resume Writing FAQ
- Cover Letter
- DD-214/ Statement of Service
- Disability Letter (Schedule A)
- Disability Letter (VA)
- Medical License
- PCS Orders
- Performance Appraisal
- Professional Certification
- Separation Notice (RIF)
- SF-50/ Notification of Personnel Action
*Accepted documents may be required for some applicants depending on which eligibility options you’re applying for, see the list below for details for each eligibility. If you need help submitting documentation, please see Applicant Help Site – Documents . If you are still unsure what documents might be required of you, please contact the FDA Applicant Help Desk before the announcement closes. For transcript submission requirements, see the Education section.
Current and Former Federal Employees:
To properly verify eligibility and time-in-grade, you must submit the following:
- SF-50 from your most recent Promotion, Within Rate/Grade Increase (WRI/WGI), Appointment, or Separation showing you are/were in the competitive service and the highest grade or promotion potential held. SF-50 submitted cannot be an annual pay adjustment or award. Your SF-50 must show the following information:
Learn more on the USAJOBS SF-50 Help Page . Schedule A:
Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Learn more on the USAJOBS Individuals with Disabilities Site .
Displaced HHS employees:
If you are a former Department of Health and Human Services employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under CTAP, you must still be found well-qualified for this position. See the How You Will Be Evaluated section for the agency’s definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site .
- Active Duty Members (Veterans Opportunity to Work, VOW to Hire Heroes Act of 2011): submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
- Parents of Deceased or Disabled Veterans (Gold Star Fathers Act of 2015): submit a copy of the deceased or disabled veterans’ DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans’ Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
- Widow or Widower: submit a copy of the deceased or disabled veterans’ DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans’ Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
- Spouse of a Living Veteran: submit a copy of the veterans’ DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans’ Preference, and Documentation of Veteran’s Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.