Expertise: Biomarkers, Cancer Interception, Disease Area Strongholds, Tumor Microenvironment
Craig Tendler, M.D. is Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care at Janssen Research & Development, LLC. In this position, he is responsible for creating robust development plans and data generation activities for all products in the oncology portfolio, from late development through registration and lifecycle management. He works closely with Early Development and the Disease Area Strongholds to implement a seamless end-to-end oncology clinical research strategy that incorporates compelling science and addresses areas of high unmet medical need.
Prior to this role, Craig was Vice President of Medical Affairs for Tibotec Therapeutics and then Ortho-Biotech, where he led approximately 50 medical affairs professionals in lifecycle management and data generation for the Oncology and Virology franchises. He played a key role in addressing with United States and European Union health authorities the safe and appropriate use of a product for the treatment of anemia caused by chemotherapy, helping to shape public policy by conducting extensive research, education and risk minimization efforts.
Craig has overseen and coordinated 11 major drug approvals by national regulatory agencies, including five by the United States Food and Drug Administration (FDA). Most recently his team worked in collaboration with the FDA and the European Medicines Agency to secure the expeditious worldwide approval of Janssen’s treatment for metastatic castration-resistant prostate cancer. In 2013, Craig and his team were instrumental in achieving four FDA breakthrough designations for investigational drugs in development for various hematologic malignancies– in collaboration with our co-development partners.
Prior to joining Janssen Research & Development, Craig was the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, he has served as Assistant Professor of Pediatrics at the Mount Sinai School of Medicine in New York City and was a research fellow at the National Cancer Institute in Bethesda, Maryland.
Craig earned his undergraduate degree from Cornell University, Ithaca, New York and graduated from the Mount Sinai School of Medicine, New York City, with high honors. He is board certified in pediatrics with a subspecialty in hematology-oncology.