Craig Tendler, M.D. is Vice President and Global Head of Clinical Development, Diagnostics, and Medical Affairs for the Oncology Therapeutic Area at Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this position, he is responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio, from proof of concept through registration and lifecycle management. He works closely with teams in early development and the disease areas of focus to implement a seamless end-to-end oncology clinical research strategy that incorporates compelling science, broad clinical trial access to diverse populations, and addresses areas of high unmet medical need.
Prior to this role, Craig served as Vice President of Medical Affairs for Tibotec Therapeutics and then Ortho-Biotech, where he led medical affairs teams in lifecycle management and data generation for the Janssen Virology and Oncology franchises.
Craig has overseen and coordinated more than 30 major drug approvals by national regulatory agencies, including at least ten NDAs by the US Food and Drug Administration (FDA). He and his have team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of Janssen’s treatments in prostate cancer, hematologic malignancies, as well as for lung and bladder cancer. Further, together with his team, Craig has been instrumental in achieving 11 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions.
Prior to joining Janssen, Craig served as 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/Hematology-Oncology at the Mount Sinai School of Medicine in New York City and as a research fellow at the National Cancer Institute in Bethesda, Maryland.
Craig earned his undergraduate degree from Cornell University, and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society.