This is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, establish and oversee any study committees (EC, DSMB, etc.), prepare for FDA submissions and audits, and drive studies to completion on time and on budget. 10+ years of hands-on clinical operations experience, with at least 5 years of experience in leadership roles, executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products.