25+ years experience in the therapeutic areas internal medicine, oncology, hematology and hematopoietic stem cell transplantation. Pharmaceutical Industry (including own company) 15+ years Broad experience in drug development and medical affairs: planning & initiation of interventional Ph I-III & observational Ph IV studies, protocol development, medical and safety monitor, support of close out, data analysis, data interpretation, clinical study report development, reporting of studies (abstracts, presentations & publications) Planning and implementation of medical affairs plan, management investigator initiated studies Led advisory board, steering committee, investigator meetings. Interactions with KOL & investigators Interactions with CRO, affiliate organizations, external partners.  Budget development & management Swiss Regulatory Agency (1.75 years) Responsible for clinical review of module 1, 2 & 5 documents including clinical overview, summaries of safety & efficacy, clinical study reports Ph I-III studies  Final decisions on new drug applications, applications for indication expansion & label changes  Worked with different procedures (standard, fast track, orphan designation) Interactions with FDA & sponsors at pre-submission meetings Clinical Research Organization (1 year) Medical monitoring of phase III studies  Contribution to proposal development, presentations at bid defense meetings Support feasibility assessment  Training in indications Registries (1.25 year) Data analysis plan development, data analysis, data interpretation, abstracts and publications Contribution to data collection & data management Clinical Medicine (+ 10 years) Residencies and training for board certifications in academical centers Staff member bone marrow transplant unit, department internal medicine Specialties Board certified Internal Medicine, Oncology, Hematology

 therapeutic areas