Dr. Kenneth Gorelick
DR. Gorelick has over 30 years of experience in developing drugs, biologics, and medical devices in the human health care sector.
He is currently a consultant to the biopharmaceutical industry. Dr. Gorelick has expertise with numerous approvals of BLAs, NDAs, and MAAs. He has held Vice President of Global Clinical Research and Development at Dupont Merck Research Laboratories, Inc. a research-driven pharmaceutical company.
He was also Vice President of Drug Development and Chief Medical Officer at Genelabs, and a biotechnology company focused on infectious and autoimmune disease. As a consultant, he frequently acts as Chief Medical Officer for smaller companies and global clinical lead for larger ones.
A brilliant teacher and outstanding communicator, Dr. Gorelick was Clinical Associate Professor of Medicine at Stanford University until 2000.
He has a B.S. from the State University of New York at Buffalo and a M.D. from Weill Medical College of Cornell University.
Dr. Gorelick is Board Certified in Internal Medicine and Pulmonary Diseases and is a Fellow of the American College of Physicians and the American College of Chest Physicians. He is currently a consultant to the biopharmaceutical industry.
Dr. Gorelick has expertise with numerous approvals of BLAs, NDAs, and MAAs. He has held Vice President of Global Clinical Research and Development at Dupont Merck Research Laboratories, Inc. a research-driven pharmaceutical company. He was also Vice President of Drug Development and Chief Medical Officer at Genelabs; a biotechnology company focused on infectious and autoimmune disease.
As a consultant, he frequently acts as Chief Medical Officer for smaller companies and global clinical lead for larger ones. A brilliant teacher and outstanding communicator, Dr. Gorelick was Clinical Associate Professor of Medicine at Stanford University until 2000. He has a B.S. from the State University of New York at Buffalo and an M.D. from Weill Medical College of Cornell University.
Dr. Gorelick is Board Certified in Internal Medicine and Pulmonary Diseases and is a Fellow of the American College of Physicians and the American College of Chest Physicians.
“I worked very closely with Dr. Gorelick for nearly a decade on an innovative development program in infectious disease. His approach to development was thoughtful and innovative. He led very productive meetings with regulators and contributed significantly to our program.''
Vincent A Fischetti, PhD, Professor and Head of Laboratory of Bacterial Pathogenesis Rockefeller University
“In my long career, I have never met an individual with such a large and complete spectrum of experience and expertise. Unique medical knowledge and understanding of immunology. Very experienced drug developer with huge expertise in regulations and FDA and global regulatory authorities interactions. Ken has a unique skill-set in writing. Incredible talent in regulatory documents writing and in publications with a proven record of achievements.”
Fabio Cataldi, MD, Vice President and Therapeutic Area Head Gastroenterology, Arena Pharmaceuticals
“My team was extremely satisfied with our collaboration with Dr. Gorelick. He possesses depth and breadth of specialist knowledge in Drug Development, and he made excellent use of his expertise, even when handling extremely complex issues. Due to his excellent capacity for analysis and synthesis, he looked at problems from different perspectives and easily and rapidly identified various options for action and he contributed actively to new solutions and advocated their implementation.
Dr. Gorelick is conscientious, diligent, and always ready to take on more responsibilities while delivering a very high standard of quality of work. More importantly, he acted independently and demonstrated exceptional initiative and commitment to our project as well as a high level of motivation and dedication. He had a lot of ideas that could be put into practice successfully, always regarded challenges as an opportunity, and capitalized on the possibilities that new situations yielded.
From my personal perspective, I find it very rare that an external collaborator has the will and motivation to make an effort and truly integrate into the team, which Ken did magnificently. I respect him very much not only for his knowledge and experience but even more for his wise, genuine, humorous, and human touch which encourages teams to persevere towards a common goal.''
Ivana Labudovic, MD, Vice President Late Development, Galapagos
“I had the pleasure of working with Dr. Ken Gorelick for a year where Ken consulted as to our company’s part-time Chief Medical Officer. Ken’s knowledge of clinical development, protocol design, and regulatory strategy were tremendously valuable. His intelligence, presence, and experience helped our team make great progress with regulators - his strength in both oral and written communication with major health authorities is among the best I’ve seen. Additionally, he supported our diligence conversations with blue-chip investors as we prepared for becoming a publicly-traded company. Ken’s diverse set of experiences and talents meaningfully contributed to our overall trajectory during a key growth phase of the company.”
Paula Ragan, CEO, X4 Pharmaceuticals