[Remote] Senior Program Manager
Note: The job is a remote job and is open to candidates in USA. Natera is a global leader in cell-free DNA testing and personalized genetic diagnostics, with the Foresight Diagnostics business unit focused on non-invasive cancer detection. The Senior Program Manager will lead complex diagnostic and medical device product development programs from early development through clinical trial launch, regulatory submission, and lifecycle activities, coordinating cross-functional teams and deliverables in a regulated environment.
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
Skills
- 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; 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
- Experience supporting clinical trial execution and readiness through FPI preferred
- PMP certification or equivalent preferred
Benefits
- Remote or on-site work in Boulder, CO
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with company match
- Generous paid time off and company holidays
- Additional wellness and work-life benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
- Free testing for Natera employees and their immediate families
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401(k) benefits
- Commuter benefits
- Employee referral program
Company Overview
Company H1B Sponsorship