Physician (Regulatory Scientific Reviewer)

Job Title

Job Description

Performs comprehensive clinical and scientific evaluations of a broad range of regulatory submissions, INDs, IDEs, BLAs, PMAs, and 510(k)s, assessing clinical trial design, safety, efficacy, and benefit-risk to support regulatory decision-making.

Leads and contributes to the development of clinical guidelines, regulatory policies, and Federal Register publications, while collaborating with multidisciplinary teams, advisory committees to resolve complex scientific and regulatory issues.

Preparing high-level briefing materials for senior leadership, responding to Congressional and public inquiries, and representing the Agency in national and international scientific, regulatory, and public health forums.

Evaluates complex statistical analyses and endpoints in collaboration with biostatisticians to ensure robustness of clinical evidence.

Coordinates and leads interactions with sponsors, including formal meetings pre-IND, end-of-phase, pre-submission), providing clear regulatory and clinical recommendations.

Participates in inspections and compliance activities where clinical expertise is required and contributes to enforcement decisions when safety or regulatory concerns arise.

Identifies and analyzes areas for new policies to be formulated and developed with expanded the types of biological products entered into clinical studies, including studies of gene and cellular therapy products.

Department of Health and Human Services