SVP Global Regulatory & Quality Science
Mr. Stonecypher has over 25 years’ experience in the life science industry in research, development, and commercialisation of novel human medicines. An expert in Regulatory Affairs and Quality, James is passionate about rapidly advancing innovative therapies for high unmet needs and improving access to medicine.
James has held senior leadership roles at major and emerging biopharmaceutical companies in the US and Europe, including Amgen, Allergan, Micromet, and BioNTech, leading global regulatory strategy and health authority interactions for investigational and commercial products. James has worked extensively in oncology with biologics, small molecules, combination products, and advanced technology products, including cell & gene therapies. James holds a BSc in Biological Sciences from the University of Southern California (USC) and a MSc in Regulatory Science from the Johns Hopkins University.