Henry Durivage, PharmD

Associate Director for Regulatory Affairs and Clinical Research Systems

Thirty-years of experience in clinical research makes Dr. Durivage well-suited to be the Associate Director for Clinical Trials within YCCI’s ORS. Dr. Durivage has experience in the direct oversight of clinical research operations at two comprehensive cancer centers. His leadership at the Cancer Institute of New Jersey resulted in an “outstanding merit” designation of the clinical trials shared resource. Dr Durivage served as a project manager for three pivotal trials during his ten years as Director and Senior Director of Clinical Affairs at Theradex Systems, Inc. In this role, he provided expertise in coordinating research among a variety of stakeholders, budgeting for clinical trials, overseeing projects to completion and ensuring compliance with Federal regulations. At Theradex he served as a leader of quality assurance activities for the NCI’s Clinical Trials Monitoring Branch and provided insight and experience in the conduct and oversight of government-sponsored clinical research. Part of this role included quality assurance training of investigators at several cancer centers. In his final two years at Theradex, Dr. Durivage served as the Vice President of Clinical Trials Integrity. In this role, he investigated potential clinical research integrity issues in a variety of cancer and non-cancer related disciplines and developed action plans with investigators and institutional personnel to resolve the issues. His ten years of experience as a clinical pharmacist provided the experience necessary to consult and work closely with investigators, inpatient and outpatient nurses and other personnel involved in the conduct of clinical research and care of research subjects. Dr. Durivage’s experience provides the ability to oversee many aspects of an institutional clinical research program, including determining the feasibility of research projects, allocating resources, budgeting for resource needs, communicating with project teams, biostatisticians, bio-specimen and pharmacokinetic shared resource leaders, and establishing performance metrics and benchmarks with which to measure the impact of improvement initiatives.