Staff Fellow/Visiting Associate -- Interdisciplinary Scientist

OFFICE OF VACCINES RESEARCH AND REVIEW (OVRR)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Become a part of an agency that touches the lives of every American!

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Review Management and Regulatory Review (DRMRR), Regulatory Review Branch 3 is recruiting an Interdisciplinary Scientist to serve as a Staff Fellow.

The Office of Vaccines Research and Review (OVRR) is an Office within CBER. The mission of OVRR is to protect and enhance public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products. OVRR oversees the development and regulation of a wide variety of biological products, including preventive and therapeutic vaccines against current and emerging viral, bacterial, and parasitic infectious diseases, live biotherapeutic products, and allergenic products. In addition to performing regulatory review of product quality, safety and effectiveness, the Office conducts applied scientific research related to the products that it regulates, develops relevant regulatory policies, and supports other agencies and center components involved in ensuring compliance with CBER biologics regulations.

RESPONSIBILITIES: The selected candidate will be part of a cutting-edge and fast-paced scientific and regulatory environment. Specifically, the candidate will perform the following major duties:

Assess the developmental program during the pre-IND and IND phases for bacterial and viral vaccines, especially those with novel adjuvants, and live biotherapeutic products.
Lead multidisciplinary review teams and conduct scientific and regulatory review of Investigational New Drug applications (INDs), Biologics License Applications (BLAs), and pertinent correspondence and related documents for scientific and medical content. This will include the evaluation of product manufacturing and characterization, animal safety data, and design of proposed clinical studies.
Provide summaries of IND and BLA submissions and serve as a source reference for contents of specific INDs and BLA submissions leading to policy making or regulatory actions relevant to preventive and therapeutic vaccines for infectious disease indications, live biotherapeutic products and allergenic products.
Prepare official correspondence for communicating agency positions on regulatory matters and provide responses to telephone inquiries regarding scientific review issues related to vaccines and related products.
Contribute to guidance and policy development activities relevant to vaccines and related products and discuss scientific review issues related to vaccines and related products at conferences and other scientific forums with appropriate experts and industry representatives.
Independently apply knowledge of data mining to gather, analyze, model, and interpret quantitative and qualitative information, anomalies, patterns, and correlations among datasets. This will include the development of approaches for the validation, integration, reconciliation, and standardization of data.
Analyze datasets to determine their quality and informational content for their use in regulatory analysis and decision-making.
Keep abreast of evolving and state of the art regulatory policies and procedures and data/information science, data tools and best practices.
Draft recommendations, most of which will be technical in nature, to describe data science activities, analysis, results, and conclusions to assist in supporting and advancing vaccine regulation.

BASIC QUALIFICATIONS: These positions are multidisciplinary, and applicants will be required to meet the specific qualification requirements of one of the applicable occupational series: General Natural Resources Management and Biological Sciences (RG-0401), Microbiology (RG-0403), or Chemistry Series (RG-1320).

ADDITIONAL QUALIFICATIONS: A Ph.D. or equivalent advanced degree (Sc.D., or PharmD, etc.) with a strong research background in bacteriology, virology, biology, microbiology, biochemistry, molecular biology, or immunology is required. Candidates are expected to be proficient in applying relevant scientific knowledge and research experience to support multi-disciplinary scientific review of regulatory submissions.

PREFERRED SPECIALIZED EXPERIENCE: The candidate should have experience evaluating/analyzing standardized study data as required by the FDA. In addition, the candidate must have strong collaborative skills, excellent written and oral communication skills, and evidence of leadership potential. Postdoctoral experience is highly preferred. Also, knowledge of federal regulations applicable to drugs, biologics, and medical devices is helpful but not a requirement for consideration.

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 further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

SALARY: Salary is commensurate with education and experience and includes an excellent benefits package.

LOCATION: FDA White Oak Campus in Silver Spring, MD; Telework opportunities may be available, as determined by current Agency policies.

CONDITIONS OF EMPLOYMENT: This position will be filled through the FDA’s Staff Fellowship Program, with an initial appointment period followed by opportunities for renewal. Applications will be accepted from all groups of qualified candidates, including U.S. citizens or non-U.S. Citizens holding valid immigration status and work authorization at the FDA. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and during the initial appointment there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.

One-year probationary period may be required.
Official Transcripts required.
Background and/or Security investigation required.
If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959, must be registered with the Selective Service System or have an approved exemption. Visit the Selective Service System for more info.
Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office webpage.
Non-US and permanent residents are required to have resided in the United States for a minimum of three of the last five years.

HOW TO APPLY:Submit a statement of interest, Federal Resume* and a cover letter to CBER.Employment@fda.hhs.gov. Full applications with all supporting documents (i.e., transcripts, names/contact information for three references, proof of U.S. citizenship or lawful permanent residency status, and other supporting documentation) should be submitted by May 17, 2024. Applications will be reviewed on a rolling basis. Please reference Job Code: OVRR-24-03-CJP

*For more information on what to include in your Federal Resume, please click on the following USAjobs.gov link: https://www.usajobs.gov/help/faq/application/documents/resume/what-to-include/

ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:

HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status