- 30+ years in global clinical development, medical affairs and translational research.
Global Clinical Development of Drugs/Devices/Diagnostics; Global Clinical Operations (registration, launch, post-launch, and study publications); Pharma Executive; Scientific and Industry Experience in Rheumatology/Autoimmune/Inflammatory Diseases, Oncology, and Hematology; Compliance, QA and Regulatory; Tenured Professor of Immunology.
MD from University of Salamanca, Spain and PhD from University of Wurzburg, Germany.
More than 100 publications and 150 abstracts.
PROFESSIONAL EXPERIENCE HIGHLIGHTS:
Chief Medical Officer, Crescendo Bioscience / Myriad Genetics
Defined and executed global clinical development program covering genetics, genomics, and proteomics, and including prospective clinical trials in rheumatoid arthritis treated with anti-TNFs. Responsible for clinical research and development; biopharma collaborations; and companion diagnostics, market access, health economics, and medical affairs activities related to personalized medicine in rheumatology. Created clinical dossier, clinical development program, publication strategy, and clinical study program leading in 2013 to Inc500 #7 in the US and CMS and private payer coverage for Vectra DA companion diagnostic test. Member of the Myriad Genetics Research Council. Established an R&D, biostatistics, and medical affairs organization (with SVP, VPs, senior/associate directors, CRAs, MSLs, and publications and program managers). Served as executive, scientific, clinical, and medical leader of the company, contributing to IPO planning and acquisition of the company in 2014 for $270M (4x valuation since 2012).
Vice President, Clinical Development and Medical Affairs, Becton Dickinson Biosciences
Provided executive, clinical development, and medical affairs leadership. Responsible for worldwide regulatory trials (US, EU, China) and investigational clinical studies in onco-hematology (leukemias/lymphomas), infectious diseases, and regenerative medicine, including pre-IDE, PMA, HUD, and 510(k) IVD notifications to the FDA as well as health economics studies for commercial team and reimbursement agencies. Established a clinical development and medical affairs team including a clinical operations director, project leads, CRAs (US, EU, and China), compliance/auditing/documentation specialist, clinical laboratory manager, and technicians. Collaborated to develop organization, systems/EDC, and processes development.
Global Head, Cardiovascular Clinical Development and Medical Affairs, AbbVie
Leader of global clinical development and medical affairs team supporting the cardiovascular therapeutic area ($2B+ in 2007 sales), including studies in diabetes and inflammatory atherosclerosis. Responsible for Phase 3 and 4 clinical development, MSL organization, investigator-initiated studies, publication, CME, medical information, and educational activities.
Medical Director, Immunology Clinical Development and Clinical Affairs, AbbVie
Part of medical team responsible for Phase 2, 3a, 3b, and 4 clinical development of adalimumab
(HUMIRA). Clinical leader and medical monitor of Phase 2 trial evaluating delivery system of HUMIRA to support pre-IND, sNDA notification, EMEA, and other registrations worldwide as well as Phase 3b open-label studies (2000+ patients) and extension studies to monitor HUMIRA long-term efficacy and safety data.