Senior Program Manager

Natera•US Remote, CO

3d•$119,000 - $148,700•Hybrid

About The Position

Foresight Diagnostics, a Natera company, is seeking an experienced Senior Program Manager to lead complex diagnostic and medical device product development programs. This role involves managing programs from early development through clinical trial launch, regulatory submission, and product lifecycle activities. The Senior Program Manager will act as a senior cross-functional leader, guiding core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations. They will be responsible for decision-making, issue resolution, risk management, and milestone achievement in a highly regulated environment. This is a hands-on role requiring direct involvement in key deliverables such as Design and Development Plans (DDPs), design reviews, DHF documentation, change orders, and regulatory submissions. Programs may cover new product development, mature products, research programs, and clinical trial assay activities. The role also supports IDE, IVDR, and 510(k) activities, driving program readiness for First Patient In (FPI). For CDx programs, the individual will collaborate with CDx development and biopharma partnership teams to align clinical trial assay and CDx strategies.

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.
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 Haves

Experience supporting clinical trial execution and readiness through FPI preferred.
Experience with assay, software, and systems development; NGS diagnostics and/or MRD experience strongly preferred.
PMP certification or equivalent preferred.

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.