Linda Robertson, Ph.D.

Senior Regulatory Affairs Advisor

Linda is a Principal at Vincere Consulting, LLC, providing strategic expertise in international biologic and small molecule drug development, including personalized medicine. She has more than 20 years of management experience in regulatory affairs in large global pharmaceutical companies, small biotechnology companies and startups. Her career has been based on the development of science-based, innovative regulatory approaches to facilitate development of treatments for serious, life-threatening diseases across a variety of therapeutic areas. Linda embarked on consulting after serving as the Vice President of Regulatory Affairs at Ignyta until its acquisition by Roche in 2018. During her tenure at Ignyta, she successfully led global expedited regulatory designations for entrectinib in patients with NTRK fusion-positive tumors, expanding from the existing U.S. Breakthrough Therapy Designation to include the EU PRIME Scheme and the Japanese Strategy of Sakigake. Prior to Ignyta, she served as Vice President of Regulatory Affairs and Quality Assurance at Intercept Pharmaceuticals where she led the EU and US approval of Ocaliva® for treatment of Primary Biliary Cholangitis, a rare, life-threatening liver disease. Prior to this, she was a key member of the leadership team at a series of biotechnology companies developing personalized therapies to treat cancer. She served as Vice President of Regulatory Affairs and Quality Assurance at Ambit Biosciences and was a founder of Kanisa Pharmaceuticals. She also served as Director, Regulatory Affairs at Biogen IDEC, Inc. and its predecessor company, IDEC Pharmaceuticals, with responsibilities for a variety of products including Rituxan® for the treatment of non-Hodgkin’s lymphoma. Linda began her career in industry at Roche, where she held various senior regulatory affairs positions supporting CNS, oncology, antiviral and immunology products at Palo Alto, California and Nutley, New Jersey and led the U.S. approval of Tamiflu® for the treatment of influenza.  Linda received her Ph.D. in neurobiology from Northwestern University followed by additional post-doctoral training in molecular biology from the Roche Institute of Molecular Biology. She received a B.A. in biology from Lewis and Clark College where she is currently a member of the Board of Trustees and serves on the Advisory Board for the Bates Center for Entrepreneurship.