A cancer biologist, immunologist and preclinical pharmacologist with experience in the pharmaceutical industry/academia in drug discovery, pre-clinical research and clinical development and its advancement in Phase 1 and Phase 2 clinical trial for oncology and inflammatory diseases• Demonstrated expertise and successful track record in bringing two drugs from early stage pre-clinical studies to clinical trials (Phase 1 and Phase 2) in patients across diverse indications, including ovarian cancer, inflammatory bowel disease, and oral mucositis• Accomplished in cell-based assay development and optimization, target identification and validation, compound screening, lead optimization and in vivo proof of concept evaluation in animal models for cancer, IBD and other diseases• Extensive broad expertise in immunology, oncology, cell signaling, and gene regulation, managing all aspects of research and development• Skilled in bridging the gap between pre-clinical investigation and clinical trials, and identifying new indications for drug candidates currently in the pipeline• Directed and performed IND-enabling pre-clinical study• Proven leadership abilities in managing a research team, and effectively working with collaborators and contract research organizations (CROs)• Contributed significantly in multiple IND submission to the FDA and follow-up communications for development of clinical trial design and filing multiple orphan drug designation applications• Directed and Performed FDA-compliant Good Clinical Laboratory Practice (GCLP) for cancer patient samples. Developed the biomarkers for phase 2 study and directed biochemical and cell-based assays supporting in vivo efficacy, PK/PD and early safety/toxicology studies relevant to clinical strategy and IND filing• Designed Phase 2 clinical trial protocol for ovarian cancer and sponsor/site interaction in conduct of clinical trials• Excellent analytical and problem solving skills
Listed skills include Drug Discovery, Molecular Biology, Cell Based Assays, Protein Chemistry, and 12 others.