Project Toxicologist• Proactive risk assessment of potential toxicity issues related to undesired or exaggerated pharmacology, investigation or characterization of potential toxicity issues to enable candidate molecule progression from early discovery to late clinical development• Subject matter expert representing toxicology on project teams to support a diverse number of therapeutic areas (oncology, immunology, and cancer immunology) on small- and large molecule project teams• Strategic planning and execution of IND-enabling toxicology studies, author relevant regulatory documents, and address information requests from health authorities• Pharmacology and Toxicology sub-team leader, responsible for execution and delivery of IND-enabling activities and timelines across relevant functions (Translational Biology, DMPK, Pharmaceutics, CMC)

Project Toxicologist

Project Toxicologist

Discovery Toxicology: proactive risk assessment of potential target pharmacology and chemotype-related toxicity issues, preparing safety strategies, and designing and implementing studies to drive toxicology plans. Closely interact with scientists in other functional areas, including Pathologists, Clinical Pathologists, Study Directors, and Development Project Leaders with project advancement.Investigative Toxicology: In vitro assay development as predictive or mechanistic tools to characterize potential toxicity of project compounds. Issue resolution by generating hypotheses and providing technical support to drive scientific processes.

Biomarker discovery to predict drug-induced toxicity through multi-omics investigations:Characterization of cell lines to study drug-induced hepatotoxicity or cardiotoxicity, assay development to evaluate drug-induced toxicity in vitro, and coordinated with proteomics and bioinformatics groups for biomarker discovery.Toxicological study of drug delivery systems in proof-of-concept investigations: Designed and developed assays for evaluation of drug candidate-induced cytotoxicity in tissue specific cell lines.

Biomarker discovery using oxidative modification of protein amino acid residues for radiation toxicity:method development using UPLC-MS/MS to identify and quantify protein amino acid oxidation products

Protective role of Nrf2 against chemical and dietary models of organ toxicity: Developed chemical and dietary models to study organ toxicity in mammalian cells and mice. Wrote protocol amendments and obtained approval from IACUC committee to start experimentation.Developed cell-based bioassays to study alterations of signaling pathways upon stimulus of xenobiotics and mechanisms of xenobiotics-induced toxicity.Analysis techniques include UPLC-MS/MS quantitation of small molecules in biological samples, protein analysis with ELISA immunoassay or western blot, rNA extraction, gene expression analysis using real time PCR, histological staining and analysis of multiple organs.Investigating genomic Nrf2 binding sites and target genes microarray analysis: Conducted expression analysis using microarray, processed the raw data using the R program, and analyzed the results using heatmap, hierarchical clustering, and pathway networking analyses.Discovery of Nrf2 activators through high throughput screening: Developed luciferase reporter-based assay in mammalian cells, and adapted it for large scale screening of small molecules. Developed and conducted secondary assays to further screening the lead compounds from the large scale screening in vitro and in vivo.