WorldCare Clinical, LLC (WCC), a leading imaging CRO for clinical trials in the pharmaceutical, biotechnology, and medical device industries, today announced that John Tomera, Ph.D., has joined the organization as director of regulatory affairs and associate medical director.
In his new position, Tomera will be responsible for the management of all quality assurance and regulatory affairs operations, including ensuring adherence to all FDA and other regulatory authority requirements. He will also be responsible for providing medical expertise to WCC project teams and acting as WCC’s liaison to its network of medical consultants at Massachusetts General Hospital and the University of Chicago Medical Center.
“John is a seasoned clinical trials professional who brings a wealth of clinical operations and regulatory affairs expertise, and we couldn’t be more pleased to have him join our team,” said President Rick Taranto. “We believe our sponsors will find John to be a helpful and impressive addition to our team. His professional contributions have led to regulatory approvals for several medical devices and biologic drugs and his extensive knowledge and success in working with international regulatory bodies will prove invaluable as we continue to broaden our expertise in global clinical trials.”
Prior to joining WCC, Tomera served as director of regulatory affairs at Biopure Corporation in Cambridge, where he directed all aspects of pre- and post-marketing activities and submissions for a variety of pharmaceutical and medical device products to the FDA and numerous international regulatory agencies. Previously, he held the position of clinical development director of oncology agents at Point Therapeutics, and has also served international pharmaceutical, biotechnology, medical device manufacturers, and CROs as a consulting pharmacologist through his own consulting company. Tomera holds a doctorate in pharmacology from Temple University School of Medicine, and a bachelor’s degree from the University of Pittsburgh. He has also held postdoctoral posts at the Harvard School of Public Health and at the Massachusetts Institute of Technology (MIT). Subsequently, he held a faculty position as an assistant professor of anaesthesiology (pharmacology) at Harvard Medical School, with appointments in the Anesthesia Services at the Massachusetts General Hospital and Shriners Burns Institute in Boston.