Toxicologist

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 2, Band C $121,785 - $191,352.

Reviews in silico, in vitro, ex-vivo, and animal data submitted to Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biological License Applications (BLAs).

Uses non-clinical data to recommend a first-in-human (FIH) dose range that is safe within the clinical trial context and therapeutic in patients.

Communicates conclusions on the first-in-human (FIH) dose range, and the clinical limit dose to the multidisciplinary review team and proposes clinical safety monitoring based on nonclinical data.

Provides comprehensive summary and integrated evaluation of the non-clinical data submitted in INDs (and amendments), NDAs, and BLAs (and supplements) are prepared for supervisory concurrence.

Evaluates whether non-clinical sections of product labeling have accurate and adequate information to communicate the safety and risks of use to patients.

Provide advice and guidance for product development regarding those aspects of the application that are within the area of activity/proof-of-concept, animal studies, and safety assessment.

Meets with industry representatives to discuss non-clinical studies needed in support of INDs, NDAs, or BLAs.