Paris Cedex 13
Large experience in the pharmaceutical industry field, at different managerial national and global positions including Drug Development, from preclinical translational research to late stage clinical development, Medical Affairs, Regulatory Affairs, Market Strategy, and Communication aspects.
Main therapeutic areas: Oncology, Diabetology, Cardio Vascular, Gene Therapy, Orphan Diseases
- Developed international product development strategy and conceived development plans - Designed and managed clinical studies worldwide Phases I, II, III, and IV - Created 5 Medical Departments (Novo Nordisk, Zymogenetics, Transgene, Innate Pharma Boehringer Ingelheim Oncology Unit) - Built Clinical Research organisations structured to conduct clinical trials according to best standard practice (clinical development, clinical operations, clinical quality control, pharmacovigilance, regulatory affairs) - Responsible for Regulatory Affairs worldwide; interfaced with national regulatory agencies, with EMA and FDA (Scientific Advice and Protocol Assistance, IND submissions, pre IND meetings). - Extensive experience in Medical Affairs and Market strategy - Large experience in communication aspects, internal and external (IPOs, refinancing rounds, communication activities)
