Associate Director, Strategic Program Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150.3k - $195.2k / year

⏰ Full Time

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 IVD/CDx programs through development, design transfer, validation, and PMA submission • Build and maintain integrated program plans covering deliverables, resources, dependencies, decision points, and regulatory milestones • Partner with functional leaders to define objectives, development priorities, success criteria, and executable plans • Anticipate risks, identify gaps and trade-offs, and drive timely cross-functional decisions • Establish program governance, ownership, escalation paths, and accountability • Integrate assay development, design controls, software and bioinformatics, analytical and clinical validation, laboratory implementation, and submission activities • Partner with Regulatory Affairs and Quality on FDA interactions, applicable requirements, and PMA evidence needs • Coordinate assay changes, comparability or bridging studies, and transition to final CDx configuration • Lead development-gate reviews and track submission-critical evidence and documentation • Present program strategy, progress, risks, trade-offs, and recommendations to executive leadership • Translate complex scientific, operational, and regulatory issues into data-backed options and decisions • Build alignment among leaders, hold teams accountable, and escalate material issues • Provide internal program status and decision support for colleagues managing external pharmaceutical partner relationships

🎯 Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent relevant experience • 10+ years of progressive program or project management experience in molecular diagnostics, in vitro diagnostics, medical devices, biotechnology, or a related regulated field • Direct experience leading CDx or IVD development programs involving design controls, validation planning, and FDA submission preparation • Experience building and driving integrated plans across technical, clinical, regulatory, quality, software, and operations functions • Ability to lead senior cross-functional stakeholders, resolve competing priorities, and deliver results without direct reporting authority • Experience presenting complex programs, risks, and recommendations to executive leadership • Ability to connect technical decisions, resource needs, regulatory evidence, and timelines to overall program strategy

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and dependents • Free testing for employees and immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401(k) benefits • Commuter benefits • Employee referral program

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