Kathleen McCarthy Kirby

Kathleen Kirby is Head of Clinical Development Operations.  Focused primarily on supporting early phase start-up companies using novel therapies to treat rare diseases, Kathleen’s areas of expertise include gene therapy (stem cell transplantation, direct administration), global clinical program management (strategic and tactical implementation), vendor out-sourcing, and regulatory strategy.  Kathleen was responsible for Clinical Development Operations at bluebird bio and Voyager Therapeutics, in addition to supporting a number of start-ups working in gene therapy and performing grant review for CIRM.  Experience with natural history studies and enrolling challenging patient populations is a cornerstone for rare disease drug development and Kathleen has deep expertise with both.  She has participated in several global product approvals, clinical trial applications and other significant regulatory filings.  Kathleen’s primary role is to translate the company’s program strategy into an operational strategy and an executable plan