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: Pharmacology/Toxicology Reviewer positions within their Pharmacology/ Toxicology Branches.
The Pharmacology/Toxicology Branches are responsible for review of a wide variety of advanced therapies, including stem cell and functionally-mature cell based products, gene therapies, xenotransplantation products, blood- and plasma-derived therapeutics, and combination products.
The Office of Tissues and Advanced Therapies is seeking outstanding scientists and biomedical engineers with training and/or experience in pharmacological, toxicological, biological, and/or veterinary sciences to join our team of scientific reviewers!
RESPONSIBILITIES: As a Pharmacology/Toxicology Reviewer, the candidate will perform the following major duties:
Serves as the pharmacology/toxicology reviewer for regulatory submissions on a multidisciplinary team consisting of product, clinical, and pharmacology/toxicology reviewers.
Evaluation of preclinical data (e.g., in vitro and animal studies) during premarket review of investigational products.
Provides feedback to sponsors regarding the design of their preclinical development program prior to investigational new drug (IND) submissions.
Reviews preclinical data in IND submissions to determine if there is adequate support for the rationale and safety of product administration in the proposed clinical trial.
Evaluation of the nonclinical sections of Biologics License Applications (BLAs).
Presents at various scientific meetings, as applicable.
ADDITIONAL QUALIFICATIONS: Ph.D. or equivalent doctoral degree (M.D., VMD, DVM., or Sc.D. etc.) is required.
DESIRED SPECIALIZED EXPERIENCE: Experience with research projects investigating tissue-engineered, stem cell therapy, and/or gene therapy products, and experience conducting experiments in animals is beneficial.
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.
LOCATION: Silver Spring, MD
CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program. The appointment provides up to (4) years with 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 there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
If applicant is a 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.
HOW TO APPLY: Pleasesubmit your electronic resume or curriculum vitae with a cover letter containing a brief summary of your scientific accomplishments to Mercedes Serabian at Mercedes.Serabian@fda.hhs.gov and carbon copy Allen Wensky at Allen.Wensky@fda.hhs.gov. Applications and all supporting documentation will be accepted through July 9, 2021,to the e-mail addresses above. Applicants should reference job code: OTAT-21-11-BES.
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.
Additional Salary Information: Salary is commensurate with education and experience.
Internal Number: OTAT-21-11-BES
About U.S. FDA/Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) 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.