Vice President, Regulatory Affairs & Quality Assurance
Mr. Ruby has more than 20 years of experience in managing regulatory strategy and the regulatory review process at leading biotechnology companies, where he has had responsibility for more than 15 drug development programs. Prior to Assembly, Mr. Ruby was Vice President of Regulatory Affairs at Presidio Pharmaceuticals., where he oversaw regulatory strategies for the company’s HCV development programs. Previously, he was Senior Director, Regulatory Affairs at Alnylam Pharmaceuticals and at Vertex Pharmaceuticals. At Vertex, Mr. Ruby led global regulatory activities for the HCV drug Incivek™ through the start of Phase III. Earlier in his career, Mr. Ruby was a chemistry reviewer and manager for drug metabolism and pharmacokinetic reviews at the US Food and Drug Administration. Mr. Ruby earned a BA from Harvard University and an MS from the University of California, Berkeley.