U.S. FDA/Center for Biologics Evaluation and Research
Location: Silver Spring, Maryland
Type: Full Time
Required Education: Doctorate
Salary is commensurate with education and experience, including an excellent benefits package.
Telecommuting is allowed.
Internal Number: OTAT-22-21-AVM
Cell Therapies, Gene Therapies, and Plasma Therapeutic Products
Office of Tissues and Advanced Therapies (OTAT)
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)
Department of health and human services (HHS)
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting to fill multiple Staff Fellow/Visiting Associate positions to serve as Pharmacology/Toxicology Reviewers.
We encourage outstanding scientists and biomedical engineers with training and/or experience in Immunology/Immunotherapy, Molecular Biology, Cell Biology, Virology, InfectiousDisease, GeneTherapy, GeneticEngineering, RegenerativeMedicine/TissueEngineering, Pharmacology/Toxicology, and/or VeterinarySciences to apply!
DCEPT is strongly committed to bringing scientists, patient advocates, and the public together in partnership to develop novel advanced therapies, while protecting human subjects and ensuring product safety and quality.
The selected candidate will join a top group of scientists and engineers in a fast-paced scientific and regulatory environment. The candidate will work within a multidisciplinary team of scientists, clinicians, and biostatisticians to perform assessments of cutting-edge scientific and regulatory information for novel cell and gene therapy products submitted by top academics, small and large biotech companies, as well as large pharmaceutical companies. The candidate may also have opportunities to contribute to FDA policy and guidance development activities in a wide range of areas relevant to the regulation of innovative cell and gene therapy products.
RESPONSIBILITIES: As a Pharmacology/Toxicology Reviewer, the candidate will perform the following major duties:
Serves as the primary preclinical reviewer for regulatory submissions on a multidisciplinary team.
Evaluates preclinical data during premarket review of investigational products. Product types include genetically modified cells, viral and non-viral vectors for gene therapy, genome editing products, stem cell-derived products, immunotherapies, therapeutic vaccines, products for xenotransplantation, etc.
Provides science-based written and verbal feedback to sponsors regarding the design of their preclinical development program prior to investigational new drug (IND) submissions.
Reviews complex, cutting-edge preclinical programs in IND submissions to determine if there is adequate support for the rationale and safety of product administration in the proposed clinical trial.
Evaluates the nonclinical sections of Biologics License Applications (BLAs).
Represents the FDA at various scientific and regulatory meetings, as applicable.
ADDITIONAL QUALIFICATIONS: Ph.D. or equivalent doctoral degree (M.D., D.V.M., or Sc.D., etc.) is required.
PREFERRED SPECIALIZED EXPERIENCE: Experience with research projects investigating gene therapy products, stem cell therapy, and/or regenerative medicine/tissue-engineered products, and experience conducting experiments in animals is highly desirable.
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, including an excellent benefits package.
LOCATION: FDA White Oak Campus in Silver Spring, MD
CONDITIONS OF EMPLOYMENT: This position will be filled through the Service 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.
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 SSS.gov 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 website at FDA Ethics and Integrity Office.
This position is subject to Executive Order 14043, mandating covid-19 vaccination for federal employees does not currently apply.
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: Pleasesubmit your resume or curriculum vitae with a cover letter containing a brief summary of your scientific accomplishments to Iwen Wu at Iwen.Wu@fda.hhs.gov and carbon copy Mercedes Serabian at Mercedes.Serabian@fda.hhs.gov. Applications and all supporting documentation will be accepted through October 21, 2022. Please reference Job Code: OTAT-22-21-AVM.
About U.S. FDA/Center for Biologics Evaluation and Research
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.