Pharmacologist

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.

Employs advanced scientific knowledge for human dose selection that integrates medicinal products’ pharmacology, molecular and cellular biology, systems biology, and safety profile.

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

Evaluates specialized non-clinical studies, such as animal efficacy studies via the Animal Rule for medical countermeasures, as needed.

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.

Makes regulatory recommendations, such as clinical hold (INDs), and drug approval (NDAs/BLAs) decisions, based on non-clinical data.