GLOBAL MEDICAL AFFAIRS EXECUTIVE AT GENZYME. Broad expertise in industry and academia including rare genetic diseases (Gaucher, Fabry, Pompe, Mucopolisacaridoses, Familial Amyloid Polyneuropathy), multiple sclerosis and other therapeutic areas (infectious diseases, vaccines, atherosclerosis and hemoglobinopathies). Culturally sophisticated, versatile leader, spanning from discovery, early research, preclinical, clinical development and launch to product lifecycle management. Successful track record at developing US/Global Medical Affairs early and late stage portfolio strategies in close collaboration with internal and external stakeholders. Architect and catalytic agent of the medical strategy to secure large contracts, healthcare recommendations and the development of a new subsidiary. Invited speaker to international presentations. Author and supporter of scientific publications. PREVIOUSLY: GMA Director at Novartis and GSK Vaccines, Director Clinical Development at FoldRx, Drug Safety and Risk Management MD at Biogen, Medical Director at Genzyme and Director Pre-Clinical & Clinical Development at Novazyme. Dr. Ponce was the founder & CEO of PAR Biomedical Affairs, a global firm supporting the strategic planning and development of biotechnology products. SPECIALTIES include: Global Medical Affairs, early and late portfolio strategy and prioritization, pre-clinical & clinical development (phases II-IV), expanded access programs, safety/ risk management, CRO management, KOL development, centers of excellence, diagnostics, investigator initiated studies, advisory boards, copy clearance, atherogenesis, hyperlipoproteinemias, hemoglobinopathies, vaccines, orphan drugs/diseases, enzyme replacement therapy, chaperone/re-folding therapy, disease registries, basic science research. Multicultural International experience. Fluent in English/Spanish, working level Portuguese
Senior Medical Director Global Medical Affairs Rare Diseases @ From October 2015 to Present (1 month) Cambridge, MAFounder/ CEO @ From December 2007 to Present (7 years 11 months) Director Global Medical Affairs Meningitis ACWY and Early Vaccines @ From March 2015 to September 2015 (7 months) Cambridge, MassachusettsDirector US / Global Medical Affairs Meningitis ACWY and Early Vaccines @ From August 2009 to February 2015 (5 years 7 months) Cambridge MassachusettsMedical Director Clinical Development @ Clinical Development of novel therapeutics for Hereditary Amyloidosis based on the in-vivo refolding of mutated proteins From December 2008 to August 2009 (9 months) Cambridge, MAMD consultant @ Post marketing Drug Safety and Risk Management - Products for treatment of Multiple Sclerosis (Tysabri, Avonex) From June 2008 to December 2008 (7 months) Medical Affairs Director @ From 2001 to 2007 (6 years) Cambridge, MADirector Early Research, Pre-Clinical & Clinical Development @ From 2000 to 2001 (1 year) Princeton, NJAssistant Professor Human Genetics @ From 1991 to 2000 (9 years) Post Doctoral Fellow @ From 1988 to 1992 (4 years) Visiting Assistant Professor @ From 1984 to 1988 (4 years) Assistant Professor @ From 1974 to 1987 (13 years) Caracas, Venezuela
MSc, Biology/Biochemistry @ Instituto Venezolano de Investigaciones Científicas (IVIC)MD, Medicine @ Universidad Central de Venezuela Elvira León is skilled in: Clinical Development, Biotechnology, Clinical Trials, Pharmaceutical Industry, Vaccines, Medical Affairs, Clinical Research, Pharmacovigilance, Drug Development, Life Sciences, Medicine, Drug Safety, Regulatory Affairs, Oncology, Cardiology, Medical Education, Strategic Planning, Rare Diseases, Internal Medicine