Physician Project Lead / Clinical Research Director

Pharmaceutical scientist/physician with >30 years hands-on and leadership experience in various aspects of basic research (15 y), drug discovery (10 y) and drug development (15 y) in various business environments including academia (University of Brussels), big pharma (J&J, GSK), mid-size pharma (Stiefel), start-up small pharma (Barrier Therapeutics) and CRO (Biometric Research Institute). Extensive expertise in the discovery and development of New Chemical Entities and Advanced Therapies (cell and gene therapy) in the following therapeutic areas: CNS (stroke, head trauma), Dermatology (acne, psoriasis, urticaria, fungal infections) and Rare Diseases (congenital ichtyosis, primary immune deficiencies, beta-thalassemia). Main areas of expertise include biomedical measuring techniques, in vivo and in vitro models of disease, cerebral blood flow & metabolism and CNS morphology, cardiac electrophysiology, cardiovascular safety research, clinical trials, drug safety and pharmacovigilance, regulatory submissions (scientific advice, CTAs, orphan drug applications, pediatric development plans, DSURs, etc), rare diseases, early access programs, collaboration with internal depertments (CMC, regulatory affairs, pharmacovigilance, medical affairs, epidemiology, health economics, market access, commercial, legal) and external partners (CRO, academia, key opinion leaders, patient advocacy groups, regulatory agencies in EU, USA and Japan).