Craig Tendler, M.D. is Vice President, Clinical Development and Global Medical Affairs for the Oncology Therapeutic Area at Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. 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 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 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 approximately 50 medical affairs professionals in lifecycle management and data generation for the Virology and Oncology 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 more than 30 major drug approvals by national regulatory agencies, including at least ten by the United States Food and Drug Administration (FDA). He and his have team worked in collaboration with the FDA and the European Medicines Agency to secure the expeditious worldwide approvals of Janssen’s treatments in prostate cancer, hematologic malignancies and bladder cancer. Further, together with his team, Craig has been instrumental in achieving multiple FDA breakthrough designations for investigational medicines in development for various indications and in collaboration with our co-development partners.
Prior to joining the Janssen Pharmaceutical Companies of Johnson & Johnson R&D, 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 at the Mount Sinai School of Medicine in New York City and as a research fellow at the National Cancer Institute in Bethesda, Maryland.