Barbara Novak

Barbara Novak is the Associate Director of Clinical Operations Systems and Process at Kyowa Kirin USA (KKUSA). She has worked in clinical drug development for over 30-years, has been employed at KKUSA since 2009 (12+ years) with focused expertise in immunology, oncology, CNS-Parkinson’s disease therapeutic areas and more.  

She is currently a key member of the Clinical Operation Leadership Team, leads the KKUSA and EU Regional TMF Business Administrator team, Drug Development TMF Forum and is a key member of the Global TMF BA Forum. Additionally, she collaborated with Project Management and the Global CTMS Task Force and development, maintenance, and business systems analysis across the current platform for operational updates.   

Barbara leads the Clinical Inspection Readiness and Risk Quality Management teams while partnering across GxP QA for Health Authority engagements and cross functionally collaborations.  

She leads the Clinical Operational Process Improvement both regionally and globally.  

She is married, has two daughters, both college graduates, loves travel, having fun with family and friends, swimming, hiking, biking and gardening and more!