Senior Program Manager

🕒 July 23

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $119k - $148.7k / year

⏰ Full Time

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Lead complex diagnostic and medical device product development programs from early development through clinical trial launch, regulatory submission, and product lifecycle activities • Serve as program leader for core teams across R&D, Software, Quality, Regulatory, Clinical, and Operations • Drive programs through development milestones, design reviews, phase exits, clinical trial launch, First Patient In, and regulatory submission • Translate product goals and regulatory requirements into plans, priorities, and decisions • Resolve technical, operational, and organizational issues across cross-functional teams • Identify and manage program risks, dependencies, and trade-offs; escalate issues and drive decisions through portfolio governance • Communicate program progress, risks, decisions, and recommendations to functional and senior leadership • Ensure product requirements, design controls, risk management, verification/validation, and documentation are planned and executed • Author and review Design and Development Plans, DHF documentation, design review materials, change orders, and other development documentation • Support IDE, IVDR, 510(k), and other regulatory submissions • Align clinical trial assay activities with broader CDx strategy • Apply ISO 13485, IEC 62304, design controls, and regulated product development knowledge to identify gaps and anticipate risks

🎯 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 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

🏖️ 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 dependents • Free testing for employees and immediate families • Fertility care benefits • Pregnancy and baby bonding leave • Commuter benefits • Employee referral program