Dr. Karen Pinachyan

Associate Medical Director Europe, leading therapeutic areas Immunology & Neurology and Cardio-Metabolic

- Leading a country medical team with a focus on medical affairs (medical managers and MSLs) and healthcare compliance, 12 direct reports. 5 actively promoted therapeutic areas (oncology, cardiology, metabolism, respiratory, rare diseases) & portfolio of products in development (oncology, scleroderma, IBD, NASH, psoriasis, arthritis, CNS etc). Very diverse portfolio management, all lifecycle stages from phase 1 to Loss of Exclusivity.

Western European MIDI Region Cluster Headquarter - ombined therapeutic area (biggest of the company) medical head, portfolio of several products in different lifecycle stages, ~250M€ annual sales in the region, 4 blockbusters (NOAC, stroke, DPP4, SGLT2i, monoclonal antibody) - team management (4 medical team members, 2 Cardiovascular/Thrombosis & 2 Metabolism, direct reports) and functional matrix leadership of country teams (2x 13 medical managers)

Medical Team Leader, Cardio-Vascular, European MIDI Region Cluster Headquarter - built the medical affairs strategy in a newly created regional headquarter, startup environment - leadership for headquarter team (1 direct report) and country teams (14 dotted lines) - full responsibility for medical affairs in the region for 3 promoted products, 150 M€ (Pradaxa, Praxbind, Actilyse) - full responsibility for the medical budget for direct scientific support

- field based medical project leadership in cardiology/thrombosis (projects with cardiologists, anaesthesiologists, emergency and critical care, neurovascular) & respiratory (asthma, COPD, pulmonary fibrosis) - national coordination for Medical Affairs Operations in Idiopathic Pulmonary Fibrosis (matrix, lead MSL) - strong involvement in transversal project teams both national (working group) & international (roadmap)

Medical Projects (both field & HQ based) in Immunotherapy and Intensive Care & Emergency Medicine Medico-Marketing activities, KOL development, observational studies, Investigator Initiated Studies, Medical education, training for sales, field Medical Liaison activity, trial protocol proposal, CRO management Medical Information, external query management

medico-marketing activities, observational studies in Rheumatology & Internal Medicine (Rituximab)

orphan drug development, medical affairs and clinical studies, team management of 4 orphan designation EMA & FDA public relations with Stakeholders (including patients’ associations, physicians, academia, university hospitals, research institutions, bioclusters etc)

interactions with key stakeholders of the Agency (patients, HCP, learned societies etc) in a highly international environment, creation and management of the database of Interested Parties medical information activities participation in meetings of all Scientific Committees of the Agency

medical information, toxicology, pharmacovigilance, drug & product safety

- participation in clinical medical, surgical and outpatient activity - organisation of clinical staff meetings, grand rounds - scientific writing activity (research papers, books chapters) - training and courses for medical students - organisation of and participation in scientific events, workshops and congresses in collaboration with stakeholders - management of information & communication projects via internet and multimedia supports

curriculum : concept of immunotherapy, monoclonal antibodies, immunoglobulines, vaccinology, therapeutic vaccines, cancer immunotherapy, molecular biotherapies, cell and tissue therapy, regulatory issues

- Regulation and norms for Medical Devices and Biologicals - Certification procedures, CE marking, preclinical and clinical evaluation - Clinical trials of medical devices, evaluation and quality management, vigilance and risk management - Assessment of risk/benefit ratio, reimbursement issues

Clinical Research, drug development, biostatistics, pharmacovigilance

MD