Regulatory Scientific Reviewer

Duties

Performs comprehensive clinical and scientific evaluations of a broad range of regulatory submissions.

Provides guidance to sponsors across all phases of product development, ensuring that clinical protocols are scientifically sound, ethically appropriate, and capable of generating data to support approval or clearance.

Leads and contributes to the development of clinical guidelines, regulatory policies, and Federal Register publications, while collaborating with multidisciplinary teams, advisory committees, and other Centers.

Applies advanced clinical judgment to evaluate trial methodology, safety signals, product labeling, and post-marketing requirements, ensuring continued safety and effectiveness throughout the product lifecycle.

Conducts in-depth reviews of preclinical and translational data to determine readiness for human trials; assessing pharmacovigilance data, adverse event reports, and real-world evidence to identify emerging safety concerns.

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

Determines if human subjects in clinical research of investigational new drugs or biologics can be protected from unreasonable risks.