We are seeking an experienced Senior Program Manager to lead complex diagnostic and medical device product development programs from early development through clinical trial launch, regulatory submission, and product lifecycle activities.
This individual will serve as a senior cross-functional leader, bringing the program leadership, technical understanding, and judgment needed to move complex product development programs forward in a highly regulated environment. They will lead core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations, helping teams make decisions, resolve issues, manage risk, and stay focused on delivering key milestones.
This is a hands-on role. In addition to leading programs, the Senior Program Manager will work directly with development teams on key deliverables, including Design and Development Plans (DDPs), design reviews, DHF documentation, change orders, and regulatory submission activities. Programs may span new product development, mature products, research programs, and clinical trial assay activities.
The role will also support IDE, IVDR, and 510(k) activities and drive program readiness through First Patient In (FPI). For CDx programs, this individual will partner with the CDx development and biopharma partnership teams to support the clinical trial assay and IDE/IVDR aspects of the program and ensure alignment between the clinical trial assay and CDx strategy.