Vice-President, Global Project Management & Feasibility
Since February 2014
Vice-President, Global Clinical Development, Americas
November 2012 --- February 2014
Deputy Head of Global Clinical Operations
October 2008 --- October 2012
International responsibilities: Full line management of all Clinical Directors in the European Subsidiaries (UK, Holland, Germany, Hungary, France, Russia and Italy). Specific responsibilities for other countries (Argentina,...) Line Management of the Global Operations Manager Group. 9 Global Operations Managers located in 7 countries in Israel, NA and WE. Leadership role in managing internal customers and internal partners from different parts of the company. Involved in all decisions regarding: Development strategy: Prioritization and scheduling of clinical development programs across the company geographies. Clinical trials: Country allocation, setting timelines and follow-up, quality, etc. Human Resources: planning, hiring, performance evaluation, career development, etc, for all countries under responsibility. Total staff: around 100 staff in 8 countries. Procedures: Review and establishment of work procedures within the Global Clinical Operations. Finance: Budget planning and control, financial accountability. Local responsibilities: Responsible for the clinical operations of Teva in Spain as described below.
Director of Clinical Research and Medical Affairs - Spain
May 2005 --- October 2008
Clinical Trials: Full responsibility for all clinical trials performed in Spain by the company for 6 different molecules and their indications. Phase II-Phase III studies. Staff Management: Supervision of around 12 staff (Teva and non-Teva employees) for clinical research, comprised of Local Clinical Project Managers, Clinical Trial Coordinators, Clinical Research Associates and project assistants. Resource Management: responsible for planning, allocating and supervision of human resources of the medical department, including recruitment, and of the budgets of each individual project. Medical Support: Medical support to the Copaxone Marketing Team and communication with the co-marketing team in Sanofi-Aventis. Secondary support and training to the generics sales staff. Medical Affairs: Member of the Global Medical Affairs Group comprised of the Medical Directors of the 7 important countries of the company. The responsibility of the group is to provide guidance for the strategy of the company as a whole at the corporate level. International Reporting to the corporate Head of Global Clinical Operations and to the corporate Medical Director. Local reporting to the General Manager.
Head of Clinical Research
February 2004 --- April 2005
Clinical Trials: Full responsibility for all clinical trials performed in Spain by the company for around 20 different Sponsors and between 40-50 projects. Projects from Phase I studies in gene and cell therapy to large scale (70 + sites) Phase III studies. Budget: Planning and management of invoicing and expenses to meet the budget of each Clinical Trial and of the Clinical Research Department. Staff and Resources Management: Responsible for the management of the whole clinical trials personnel and resources: 25-40 staff, including resource planning, recruitment, allocation of resources, training and periodical evaluation of staff. Staff consisted of Project Managers, Clinical Trial Coordinators, Senior and Junior Clinical Research Associates, Project Assistants, Biostatisticians, Data Managers and Data-Entry Clerks. Customer relations: Support to Business Development in obtaining contracts for clinical research from existing or potential customers within the pharmaceutical industry in Spain and abroad. Suppliers: Supervision of all suppliers of services for Phidea S.L. in Spain. Due to the structure of the company, this meant direct hierarchical responsibility for around 90% of the staff in Spain (Madrid, Barcelona, Andalusia and Valencia), while reporting to the President of the company in Italy. The remaining 10% comprised the Medical Director, administration and business development which reported directly to the President.
Clinical Research Associate (CRA)
July 2002 --- February 2004
Clinical Trials Management: Full coordination in Spain and Portugal of Phase II-IV international clinical trials in the therapeutic areas of anti-HIV drugs and myocardial infarct. Supervision of trials contracted out to CROs. Data Management: Responsible for data management for those trials, starting with query generation and up to final update of the clinical trial database, using IMPACT, Oracle Clinical, eDM and I-Review. Global Development Team Member: Representative for Europe in the global development team for Atazanavir for HIV. Responsibilities were supervision of current clinical trials and life cycle management of the drug. Electronic Study File (ESF) Facilitator: Responsible for centralizing and coordinating the setup and use of ESF in BMS Spain by all staff, including training.
Clinical Trial Manager (CTM)
January 2000 --- June 2002
responsible for the International Business Unit. Clinical Trials Management: Full management of Phase II-III clinical trials in several European countries, including production management, budget management, control of objectives and invoicing. Team management of up to 10 employees. Customer relations and business development: Therapeutic Areas: mainly Central Nervous System (Multiples Sclerosis, Parkinson's Disease, Migraine), Cardiovascular and Cancer. Member of the Management Board.
Clinical Trials Coordinator
June 1998 --- January 2000
Coordination – Coordination of Phase II-III clinical trials in several European countries as part of international studies. Coordination in Spain of International Phase III trials and Observational, Phase IV studies. Data Management – Data Manager: in charge of the data management team (Data Reviewers and Data Entry Clerks) to coordinate CRF review, double data-entry, congruency checks. IT Manager – In charge of the company's IT systems. Design of the company’s network. Design and programming of databases used for project management, business development and data-entry databases. Monitoring – extensive experience in Spanish and European Hospitals.
Registros, Cientifico y Marketing
January 1998 --- January 1999
Drug registration in EU and Asia. Launch of Vinpocetina Covex, including marketing plan and rep training.
Ph.D. in Molecular and Cellular Biology, Life and Health Sciences from Université de Nantes in 1994
Diplôme d'Etudes Approfondies (Master's Degree) in Sciences de la Vie et de la Santé from Université de Rennes I in 1990
Bachelor of Science in Biology and Life Sciences from American University in 1989