Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer

Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer 

Cell Therapies, Gene Therapies, and Plasma Therapeutic Products 

OFFICE OF THERAPEUTIC PRODUCTS (OTP) 

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 Therapeutic Products (OTP), Office of Pharmacology/Toxicology (OPT) 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, Infectious Disease, GeneTherapy, Genetic Engineering, RegenerativeMedicine/Tissue Engineering, Pharmacology/Toxicology, and/or VeterinarySciences to apply! 

The Office of Pharmacology/Toxicology 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.

HOW TO APPLY: Please submit 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 Alyssa Galaro at Alyssa.Galaro@fda.hhs.gov. Applications and all supporting documentation will be accepted through March 31, 2024. Please reference Job Code: OTP-24-01-CJP. 

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. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT