Title 21 Cures Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Vaccines Review and Research (OVRR)

Division of Vaccines and Related Product Applications (DVRPA)

Application Period: Open continuously; applications will be reviewed periodically.

Area of Consideration: The Public.

United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Physician

*Multiple selections can be made (DVRPA-Wide)

Series: Physician (0602)

Location(s): White Oak Campus, Silver Spring, MD

Telework Eligible: Yes – as determined by the agency policy.

Work Schedule: Full Time

Salary: Starting at $165,000 and is set to commensurate with education and experience.

Cures Band(s): Band C

Full Performance Band Level: Band C

Travel Requirements: 25% or less

Bargaining Unit: 3591

Note: 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.

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.

Introduction:

The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

The mission of the Center for Biologics Evaluation and Research (CBER) 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 Vaccines Research and Review (OVRR) protects and enhances public health by assuring those available vaccines, allergenic extracts, and related product are safe and effective.

The Division of Vaccines and Related Product Applications (DVRPA) directs and performs the review process for investigational new drug (IND) applications, biological license applications (BLAs), and amendments with regard to biological drug products regulated by the Office. DVRPA coordinates the processing of INDs and BLAs through the other Divisions within the Office and coordinates licensing activities among the Divisions. DVRPA develops policies and procedures applicable to the review of preclinical information and clinical trial design and data submitted in support of BLAs and INDs.

Duties/Responsibilities:

The Physician conducts clinical reviews and requires a scientific medical knowledge of the infectious diseases and allergy and immunology diseases being treated. The incumbent makes judgement in evaluating adverse events; understanding of clinical trial design and determines whether products are safe and effective for human use.

The Physician performs reviews, analysis and evaluation of safety and effectiveness of vaccines and related biologic and biotherapeutic products based upon scientific information from clinical trials. Conducts the preliminary evaluation and design of clinical trial methodology relating to clinical investigations.

Specifically, the Physician will:

• Complete preliminary clinical reviews, assignments and projects related to regulated products that have a national or international impact on health.
• Review the safeguards for testing experimental and/or use of approved products in humans.
• Review primary functions and activities concerned with labeling, advertising, post-market monitoring, adverse reaction evaluation, improvement of research and evaluation practices.
• Maintain cutting edge expertise of the “state of science” to incorporate the most advance theories and practices in clinical medicine, into the Division’s and Branch’s pre-market review activities.
• Evaluate plans and protocols to conduct tests and clinical trials of Investigation New Drugs (INDs) in humans, submitted to the Agency, and application amendments.
• Evaluate clinical trial reports in humans for evidence of safety, immunogenicity, and effectiveness of new preventive vaccines and biotherapeutic products submitted in support of new Biologic License Applications (BLAs).
• Provide advice and guidance regarding those aspects of the application which fall within the incumbent’s area of review expertise.

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.
• 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

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standardsas a baseline for comparing experience levels and other candidate attributes for relevant positions.

b. 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 requiredis 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.

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.

Desired Education, Experience, or Skills:

An ideal candidate would possess an active medical license in at least one state or U.S. federal jurisdiction.

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.

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 accommodationsor 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.

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), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CBER/OVRR/DVRPA Physician Cures Announcement-Month/Year (XX/XXXX)” in the subject line to: CBERHumanCapital@fda. hhs. gov AND evan.cooney@fda. hhs. gov. Applications will be reviewed periodically.

Announcement Contact:

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

Job Type: Full-time

Pay: From $165,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Silver Spring, Md 20993: Reliably commute or planning to relocate before starting work (Required)

License/Certification:

• BC/BE (Required)
• Medical License (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: In person

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