SVP Clinical Development at MEI Pharma
Pharmaceutical executive dedicated to the development, regulatory approval and commercialization of innovative therapeutics. Physician scientists with 20+ years experience in clinical research and medical affairs in small (up to 50 employees) and mid-size (up to 1,500 employees) companies, public (n = 5) or venture-backed (n =3), including 14 years as chief medical officer or vice president.
Board-certified hematologist and medical oncologist, I have focused on developing drugs for solid tumors, malignant and non-malignant hematologic diseases, and have worked in other therapeutic areas, including neurology, autoimmune diseases, pain and dentistry. I have developed a broad range of compounds, including small molecules, cytokines, antibodies, cancer vaccines, immunotoxins, and radiotherapeutics.
I have designed and conducted all stages of clinical trials, encompassing first-in-human, proof-of concept, pivotal and post-marketing studies. Hands-on experience in clinical operations, regulatory affairs, pharmacovigilance, data management, and analysis. Have successfully managed multinational placebo-controlled trials.
Broad experience interacting with regulatory authorities (FDA and EMA). Responsible for the medical sections and have successfully filed two INDs, two sNDAs, one BLA, and one MAA. Presented at two FDA Advisory meetings, all leading to product approval.
Skilled at establishing credible rapport with management teams, board of directors, and corporate partners. Member of the clinical/regulatory committee of two corporate alliances. With the CEO and CFO, involved in several rounds of financing at private and public companies.
This background positions me to lead the development function of a start-up to mid-size biopharmaceutical company.
Specialty: Pharmaceutical development. Clinical research. Medical affairs. Oncology. Hematology. Management. Clinical consulting.