James Smith

Experience

1. Scientific Associate Director

   Bristol-Myers Squibb

   Jan 2025 — Present · New Brunswick, NJ, US

   In my current role, I serve as the Project Toxicologist for multiple R&D projects covering diverse therapeutic areas and modalities, with with a focus on treatments for psychiatric and neurological disorders. This includes oversight for the design and execution of all nonclinical safety programs to support the development of these compound from start of Clinical Development to market authorization.Specifically, I am responsible for designing and managing all in vivo and in vitro toxicological studies related to my large and small molecule projects according to ICH and other guidelines, interpreting the results of these studies and compiling them in applications for clinical trials and new drug applications. This support also includes ongoing risk assessments for process changes (e.g, chemical impurities, leachable chemicals), clinical findings and emerging literature (e.g, competitor safety data).Core responsibilities include authorship of INDs/CTAs, IBs and updates (Ph II, Ph to INDs in addition to drafting PIPs, Tox study protocols, Target Liability Assessments, and rapid responses to Regulatory Authority requests for information.

Education

• University of Cape Town

  MSc, Cardiothoracic Surgery, Cell biology (Hons), Biochemistry, Microbiology

  1994 — 2000

Skills

• Electronic Lab Notebooks
• Assay Development
• Glp
• Life Sciences
• Drug Development
• Molecular & Cellular Biology
• Medicinal Chemistry
• Biochemistry
• In Vitro Toxicology
• Lifesciences
• Biomarkers
• High Throughput Screening
• Pharmacology
• Biotechnology
• Drug Discovery
• Toxicology
• Translational Science
• Immunoassays
• Drug Design
• Biomarker Discovery
• Microbiology
• Molecular Biology
• Ligand Binding
• Pharmaceutical Industry
• Pharmacodynamics
• In Vitro
• Biomarker Development