Senior Program Manager

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.

Responsibilities

Lead complex, cross-functional product development programs and serve as the program leader for core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations; Drive programs through key development milestones, design reviews, phase exits, clinical trial launch, FPI, and regulatory submission; Translate product goals and regulatory requirements into clear plans, priorities, and decisions that enable teams to execute; Bring cross-functional teams together to resolve technical, operational, and organizational issues and keep programs moving forward; Identify and manage program risks, dependencies, and trade-offs, escalating issues and driving decisions through a formal portfolio governance process when needed. Communicate program progress, risks, decisions, and recommendations to functional and senior leadership; Partner with development teams to ensure product requirements, design controls, risk management, verification/validation, and documentation are appropriately planned and executed; Author and review key product development deliverables, including DDPs, DHF documentation, design review materials, change orders, and other development documentation; Support preparation and execution of IDE, IVDR, 510(k), and other regulatory submissions by coordinating cross-functional deliverables and submission readiness; For CDx programs, partner with CDx development and biopharma partnership teams to align clinical trial assay activities with the broader CDx strategy; Apply strong knowledge of ISO 13485, IEC 62304, design controls, and regulated product development to identify gaps, anticipate risks, and help teams make sound decisions

Requirements

5-7+ years of experience in program management, product development, or a relevant combination of program leadership and functional experience in diagnostics, medical devices, biotechnology, clinical laboratories, or life sciences; Significant experience leading complex, cross-functional product development programs in a regulated environment; Deep practical understanding of ISO 13485, IEC 62304, design controls, and medical device/IVD development processes; Experience leading teams through design reviews, phase exits, development milestones, and regulatory readiness activities; Hands-on experience with product development documentation, including DDPs, DHF documentation, change orders, requirements, risk documentation, and design review materials; Experience supporting regulatory submissions such as IDE, IVDR, 510(k), PMA, or equivalent; Experience with assay, software, and systems development; Demonstrated ability to influence without authority, challenge assumptions, drive decisions, and resolve issues across functional boundaries; Strong judgment, problem-solving, and communication skills, with the ability to operate effectively in a fast-paced and sometimes ambiguous environment; A hands-on, execution-oriented mindset and willingness to personally contribute to critical program and product development deliverables

Nice to have

Experience supporting clinical trial execution and readiness through FPI preferred; NGS diagnostics and/or MRD experience strongly preferred; PMP certification or equivalent preferred

Benefits

Comprehensive health benefits (medical, dental, vision); 401(k) with company match; Generous paid time off and company holidays; Additional wellness and work-life benefits; Life and disability plans for eligible employees and their dependents; Free testing for employees and immediate families; Fertility care benefits; Pregnancy and baby bonding leave; Commuter benefits; Employee referral program; Additional compensation and benefits through Total Rewards program