Physician with extensive experience in hematology and oncology drug development in all phases of clinical research and strong leadership of cross functional teams resulting in drug approvals. Experienced team leader, working with regulatory and marketing teams to develop coordinated strategies for transformative therapies with novel mechanisms of action and led intrapreneurial teams developing gene therapy, monoclonal antibody, and immunotherapy drugs. Expertise includes: hiring and retaining high performing team members of the operations and medical teams, coaching and mentoring physicians with direct and matrix reporting function, and networking with key opinion leaders globally. SELECTED ACCOMPLISHMENTSDrug Approvals• Led approvals for Eltrombopag (promacta/revolade) in First Line Severe Aplastic Anemia; Jadenu (deferasirox) for iron overload/ thalassemia / including Myelodysplastic Syndrome and Sickle Cell Disease; Temozolomide for First Line Glioblastoma Multiforme and new formulation bioequivalence registration. • Prepared several teams for Health Authority meetings such as Oncology Drug Advisory Committee of the FDA, Oral Explanation of European Medicines Agency (EMA) and Scientific Advice of EMA. • Managed life cycle of drugs, post approval.Mergers and Acquisitions • Led seamless integration of eltrombopag from GlaxoSmithKline into Novartis for Hematologic Malignancies ( ex acute leukemia, myelodysplastic syndrome ) Idiopathic Thrombocytopenia Purpura (ITP) and Bone Marrow Failure, including Severe Aplastic Anemia. • Clinical Reviewer for licensing of Adakveo from Selexis, now approved for Sickle Cell Disease. Leadership• Key member of Oncology / Hematology Leadership Teams at Novartis, Merck and Schering-Plough.• Primary contact for National Institutes of Health Hematology Division for bone marrow failure and aplastic anemia including Cooperative Research and Development Agreements (CRADAs) with National Institutes of Health.• Developed clinical plans for many drugs including first in class, novel therapeutic mechanisms of action such as global development for gene therapy, monoclonal antibody, and immunotherapies drugs including Keytruda.
Listed skills include Clinical Research, Clinical Development, Clinical Trials, Drug Development, and 27 others.