Senior Program Manager Foresight Diagnostics, a Natera company, is a molecular diagnostics developer pioneering non-invasive cancer detection through cell-free DNA-based liquid biopsy technologies. Following the acquisition by Natera, we combine startup agility with the scale of a global leader in cfDNA testing. About the role 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 lifecycle activities. This hands-on, cross-functional role will coordinate core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations to move programs forward in a highly regulated environment. You will contribute directly to deliverables such as Design and Development Plans (DDPs), design reviews, DHF documentation, change orders, and regulatory submissions. Programs may span new product development, mature products, research programs, and clinical trial assay activities. You will support IDE, IVDR, and 510(k) activities and drive program readiness through First Patient In (FPI). For CDx programs, you will partner with CDx development and biopharma teams to align clinical trial assay activities with the CDx strategy. What you will do - Lead cross-functional product development programs and guide core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations. - Drive programs through milestones, design reviews, phase exits, clinical trial launches, FPI, and regulat
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Senior Program Manager Foresight Diagnostics, a Natera company, is a molecular diagnostics developer pioneering non-invasive cancer detection through cell-free DNA-based liquid biopsy technologies. Following the acquisition by Natera, we combine startup agility with the scale of a global leader in cfDNA testing. About the role 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 lifecycle activities. This hands-on, cross-functional role will coordinate core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations to move programs forward in a highly regulated environment. You will contribute directly to deliverables such as Design and Development Plans (DDPs), design reviews, DHF documentation, change orders, and regulatory submissions. Programs may span new product development, mature products, research programs, and clinical trial assay activities. You will support IDE, IVDR, and 510(k) activities and drive program readiness through First Patient In (FPI). For CDx programs, you will partner with CDx development and biopharma teams to align clinical trial assay activities with the CDx strategy. What you will do - Lead cross-functional product development programs and guide core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations. - Drive programs through milestones, design reviews, phase exits, clinical trial launches, FPI, and regulat
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