Dr. Frank Gary Renshaw
Clinical Development Lead; Consultant (fractional)
About
Doctor of Osteopathic Medicine, board-certified in Internal Medicine, Oncology, and Hematology, with active medical licensure in Michigan, Texas, Pennsylvania, West Virginia, New Jersey, and New York. Over two decades of pharmaceutical oncology and hematology drug development experience, with leadership in more than a dozen successful NDAs and over 30 INDs and EMA first-in-human submissions.Passionate about building high-performing clinical organizations and advancing transformative oncology therapiesTherapeutic Focus Areas:Breast cancer, ovarian cancer, colorectal cancer, NSCLC, hepatocellular carcinoma, pancreatic cancer, soft tissue sarcoma, multiple myeloma, and gastrointestinal cancers.Track record includes:12+ NDAs and global registration25+ successful IND submissions (US & EMA)Global Leadership of FIH, proof-of-concept, and Phase III programsExperience across solid tumors, hematologic malignancies, non malignant heme and internal medicine, immunology, cell therapy and targeted agentsFormer CMO and Head Clinical Development with deep expertise in;Early Development strategy and logisticsClinical pharmacology and translational medicineRegulatory submission and DSUR oversightProgram rescue and lifecycle optimizationData integrity and patient safety governanceCurrently leading clinical development at Mirror Biopharma, advancing T-cell therapy programs in Colorectal cancer and immuno-oncology as well as focusing on Phase I/Phase II drug development at Radyus Research (both fractional positions). Open to additional fractional positions or full time opportunities.
United States
Greater Philadelphia
Biotechnology
Oncology Clinical Research, Clinical Study Design, Clinical Strategy, Trial Management, Regulatory Compliance, Global Drug Development, Global Regulatory Compliance, Clinical Research, Clinical Operations, Executive Management, Leadership, Strategic Planning, Statistical Data Analysis, Online Lead Generation, Business Strategy, Medical Writing, Pharmaceuticals, Biopharmaceuticals, Requirements Analysis, Pharmaceutical Sales
Experience

Clinical Development Lead; Consultant (fractional)
Radyus Research
Atlanta, GA
Dr. Frank Gary Renshaw's Contact Information
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