Theresa Janke has over 15 years of experience in the biopharmaceutical industry, including clinical research and operations, alliance and program management, and business operations. She’s worked in diverse fields including immunotherapy, gene therapy, oncolytic virus therapy, and medical devices. She was a founding member of the management team at 4DMT, and is co-founder and board member of IGNITE Immunotherapy.
Theresa started her career in clinical research in medical devices with Allergan and Abbott. She later expanded into oncology therapeutics R&D, serving as Clinical Project Manager and Director of Clinical Operations at Jennerex Biotherapeutics, a pioneer in intravenous oncolytic virus immunotherapy. There she directed and conducted execution of clinical trials with Pexa-Vec (JX594, an engineered oncolytic vaccinia virus), including the first randomized Phase 2 oncolytic immunotherapy trial to show a statistically significant survival benefit (published in Nature Medicine, 2013). At Jennerex, she managed all aspects of study start-up: RFP process/CRO and specialty lab selection, protocol design/development, development of trial timelines and budgets, forecasting of clinical and non-clinical supplies, and development of trial plans, site selection, clinical site team training, and management, vendor selection and management, risk assessment and mitigation, managing internal and vendor timelines and budgets, collecting and analyzing performance metrics, compilation, analyses and reporting of clinical and safety data.
Theresa has directed multiple international partner alliances and has experience as a multi-national trial leader in the US, Canada, South Korea, Taiwan, China, Germany and France.
At Celgene, as Director of Clinical R&D Strategy and Alliances, Theresa worked closely with the SVP of Clinical R&D for hematology-oncology; she led the development of Clinical Research and Development (CR&D)-Regulatory 5-year integrated Clinical Development Plans (CDP) for each disease area within the hematology-oncology group.
Theresa graduated from the University of California, Santa Barbara in 1996 with a Bachelor of Science in Biopsychology. She also holds professional certificates from UC Berkeley in the area of clinical project management.