SME Profile

Paul Cohen BAppSc (Biomed), GradCertHlthEcon, MAIMS, MASM


Paul is currently Managing Director of an Australian-based boutique consultancy in clinical research, quality management and regulatory affairs. He also holds the position of Operations Manager for the Royal College of Pathologists of Australasia Quality Assurance Programs Pty Ltd.
Paul has over 15 years of experience in executing clinical trials in Australia, NZ, Europe and USA. He has held senior clinical research management positions with Merck Sharp & Dohme, Sanofi Aventis and Wyeth Ayerst Research and was instrumental in establishing the clinical research and medical departments for Sanofi Pasteur (Australia), Columna Pty (an Australian specialist spinal implant company) and the CRO: DevDx Clinical Pty Ltd.
As a founding staff member, he also helped establish the Australian office of the global CRO: Pacific BioPharm - now known as Omnicare. Paul's experience spans the entire development life cycle for pharmaceuticals, medical devices and diagnostics with particular expertise in global regulatory strategy, clinical trial planning, and management.
He has recently been awarded the ARCS Fellowship in Clinical Research as recognition of his sustained commitment to clinical research in Australia. He has a special passion for continuing education and professional development in the industry.
Working with both global companies as well as local start up ventures, he has successfully managed in excess of 20 clinical and health outcome projects. He is an active member of the Association of Regulatory and Clinical Scientists (ARCS), Regulatory Affairs Professionals Society (RAPS) and Drug Information Association (DIA).
Prior to joining the industry he had a very successful career as a microbiologist and laboratory manager for both private and public pathology laboratories. He is very interested and experienced in clinical diagnostics and stays abreast of the industry by maintaining membership and support of the Australian Institute of Medical Scientists (AIMS) and the Australian Society for Microbiology (ASM).