Senior Program Manager

Role Description

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.

• Lead core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations.
• Help teams make decisions, resolve issues, manage risk, and stay focused on delivering key milestones.
• Work directly with development teams on key deliverables, including Design and Development Plans (DDPs), design reviews, DHF documentation, change orders, and regulatory submission activities.
• Support IDE, IVDR, and 510(k) activities and drive program readiness through First Patient In (FPI).
• Partner with CDx development and biopharma partnership teams to support clinical trial assay and IDE/IVDR aspects of the program.

Qualifications

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

Requirements

• Lead complex, cross-functional product development programs and serve as the program leader for core teams.
• 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.
• Identify and manage program risks, dependencies, and trade-offs.
• 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.
• Support preparation and execution of regulatory submissions.
• Apply strong knowledge of ISO 13485, IEC 62304, design controls, and regulated product development.

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.

Company Description

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

• The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers, and many other professionals from world-class institutions.
• We care deeply for our work and each other.
• When you join Natera, you’ll work hard and grow quickly.
• You’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.