Subject Matter Expert - Reviewer Scientist

The SME - Reviewer Scientist will provide scientific and regulatory expertise in reviewing clinical and nonclinical data submitted in support of drug applications. This position will support projects within the FDA Center for Drug Evaluation and Research (CDER), Office of Computational Science, under the direction of the COR.

Responsibilities:

• Review clinical safety and efficacy studies submitted in support of drug applications.

• Evaluate clinical and nonclinical data for regulatory compliance, data integrity, scientific validity, and human-subject safety.

• Analyze study designs, protocols, adverse events, laboratory findings, patient narratives, statistical results, and benefit-risk evidence.

• Identify data anomalies, safety signals, protocol deviations, missing information, and inconsistencies.

• Support reviews of INDs, NDAs, BLAs, ANDAs, amendments, and supplements, as applicable.

• Prepare scientific assessments, review memoranda, technical reports, presentations, and recommendations.

• Collaborate with clinicians, statisticians, pharmacologists, toxicologists, data scientists, and regulatory specialists.

• Support projects involving drug product design, manufacturing approaches, drug quality standards, and post-market surveillance.

• Participate in CDER work groups, subcommittees, peer reviews, and scientific meetings.

• Conduct literature reviews and contribute to scientific articles, white papers, and regulatory research.

Required Qualifications:

• MD or PhD in medicine, pharmaceutical sciences, pharmacology, toxicology, epidemiology, biostatistics, clinical research, biomedical science, computational science, or a related field.

• Minimum of five years of experience as a reviewer scientist, clinical scientist, regulatory scientist, or medical reviewer.

• Experience reviewing multiple types of drug applications or regulatory submissions.

• Knowledge of FDA drug-review processes, regulatory guidance, and applicable 21 CFR requirements.

• Strong scientific writing, analytical, communication, and multidisciplinary collaboration skills.

Required Skills and Technologies:

• Clinical and nonclinical data review

• Clinical safety and benefit-risk assessment

• Regulatory compliance and data integrity

• Drug development and pharmacovigilance

• Statistical analysis and scientific research

• CDISC standards, including SDTM, ADaM, and SEND

• MedDRA and adverse-event coding

• eCTD regulatory submissions

• SAS, R, Python, JMP, or equivalent analytical tools

• Tableau, Power BI, Spotfire, or comparable visualization tools

• Microsoft Word, Excel, PowerPoint, SharePoint, and Teams

Preferred Qualifications:

• Previous FDA, CDER, pharmaceutical, biotechnology, or public-health regulatory experience.

• Experience with clinical-trial systems, safety databases, and electronic regulatory submissions.

• Experience publishing scientific articles or presenting regulatory research.

• Familiarity with AI, machine learning, natural language processing, or automated scientific data review.