As a Medical Director, I have led clinical trials from proof of concept to submission, from phase I to Phase III. I reviewed dozens of documents including protocols, charters, CRFs, SAPs. Reviewed and analyzed clinical data; interpreted and communicated key aspects to internal and external audiences. Led and/or assisted in the development, drafting, and supervised submissions to FDA and/or non-US regulatory authorities. I have sound knowledge of ICH, GCP and Good Pharmacovigilance Practices, assessment guidelines regarding clinical investigation with drugs, biologics, and medical devices. I managed my direct reports and reported to CMO as the Medical Director within the medical affairs group at PAREXEL. I recently joined NOVARTIS and provided scientific and operational expertise to the oncology clinical development in early clinical development. I am an active member of RSNA, ARRS and SNM.
The therapeutic areas in which I have worked include; 1.Oncology studies; renal cell, small/non-small cell lung, head and neck, hepatocelular, thyroid, colorectal, NHL, breast cancer, liposarcoma, 2. Musculoskeletal studies; rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, long bone fractures, spine fusion/device, osteogenesis imperfecta, 3. Cardiovascular studies; coronary, carotid, lower extremity atherosclerosis DSA, MRA, DVT, MRA, Cardiac MRI, convetional MRI, CT and Ultrasound contrast agents, 4. Others; stroke, adipose tissue distribution, Idiopathic Pulmonary Fibrosis, Hormone replacement therapy.
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