Mark Tirmenstein

Serve as a project toxicologist on small molecule drug development teams

Serve as a project toxicologist on small and large molecule drug development teams.

Serve as a toxicologist on small and large molecule drug development teams. Toxicology representative on due-diligence opportunities.

Serve as a study director/study monitor on both non-GLP and GLP studies and Drug Safety Evaluation representative on small/large molecule and siRNA drug development teams. Serve as Drug Safety Evaluation lead in meetings and interactions with regulatory health authorities. Prepare regulatory documents such as Investigator Brochure, NDA, MAA, and End of Phase II Briefing Documents. Investigate toxicity issues in Drug Safety Department by designing both in vitro and in vivo studies. Interpret data, including toxicogenomic, from investigative studies. Serve as a departmental resource in examining mechanisms of toxicity.

Conduct in vitro studies on the toxicity of pharmaceuticals. Prepare protocols and manuscripts. Supervise technicians and coop students. Represent Safety Assessment in project management and drug development teams. Develop new assays measuring oxidative stress, mitochondrial function and toxicity endpoints. Work with members of Gene Research and Bioinformatics Departments designing toxicogenomic experiments and interpreting data designed to examine hepatotoxicity.

Conduct research on the mechanisms of action of toxic chemicals and the protection afforded by antioxidants. Prepare and review manuscripts, and teach selected courses in drug metabolism and toxicology. Manage laboratory, maintain equipment and supervise workers.