Director Regulatory Affairs and Quality
Ms. McCracken has 20 years of experience in the biopharmaceutical industry with the past 13 years devoted to Regulatory Affairs, overseeing multiple biologics programs. Her experience in biotechnology/clinical research includes all phases of product development and manufacturing. Previously at GenVec, Ms. McCracken provided regulatory strategy and support for drug development of novel gene transfer therapeutic and vaccine products. She served in Quality Assurance and Quality Control roles at Human Genome Sciences and MedImmune. She successfully interfaced with the FDA, leading FDA meetings and managing several INDs.