Senior Strategic Program Manager

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $140.7k - $175.9k / year

⏰ Full Time

🟠 Senior

📋 Program Manager

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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

• Drive cross-functional programs bringing new clinical products to market and enhancing existing products, focusing on Design Control and New Product Introduction • Partner with R&D, business, operations, and engineering teams to define goals, milestones, and plans • Lead product development from early concept through commercialization and post-launch • Develop and maintain project plans, protocols, reports, and other program documentation • Track progress and communicate results through data-driven reports and updates to senior leadership • Manage Design Control gate reviews, design freezes, technical assessments, change control, and regulatory deliverables • Facilitate team meetings, drive decisions, and surface and mitigate risks • Guide trade-off and risk decisions across technical, business, and regulatory considerations • Foster collaboration and problem-solving to resolve challenges and conflicts • Coordinate joint development efforts with external partners • Manage up to 4 programs simultaneously

🎯 Requirements

• Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or a related technical discipline (or equivalent experience) required • Project management certification or training (e.g., PMP or equivalent) required • Minimum 4 years of program management experience in biotech, life sciences, or another regulated technical industry • Background in research, assay development, systems engineering, lab operations, or software development highly desirable • Familiarity with laboratory informatics systems and LIMS, sample accessioning, sequencing pipelines, and results reporting preferred • Minimum 5 years of project budget management experience preferred • Experience with software development lifecycle principles, data architecture patterns such as SOA, and agile tools such as Jira and GitLab a plus • Experience creating and maintaining complex Gantt charts, project plans, and risk/RAID logs • Expert proficiency with project management and scheduling tools such as SmartSheet or equivalent • Understanding of product development under FDA Design Controls and relevant regulations desirable, including 21 CFR, ISO 13485, ISO 15189, EU IVDR, and Section 524B for Cybersecurity • Exceptional communication and interpersonal skills • Strong organization, resilience, adaptability, time management, and multitasking abilities • Ability to work independently and contribute effectively to cross-functional teams

🏖️ 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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