Senior Manager, R&D

Responsibilities

• Lead and execute technical development of NGS-based oncology assays, including project planning, execution, and cross-functional coordination
• Collaborate cross-functionally with Research, Informatics, Stats, Software, Regulatory, Quality, and Commercial teams to support product development and launch
• Support post-launch activities, including process improvements, troubleshooting, and collaboration with Operations for commercialized assays
• Prepare and review technical documentation, including study protocols, reports, and validation documentation, to support product development and regulatory compliance
• Manage and mentor team members
• Perform and guide data analysis using statistical tools
• requirements and design control processes in a regulated environment (e.g., LDT, CAP/CLIA, product development lifecycle, change management)

Requirements

• Experience in NGS-based assay development in a regulated environment (CLIA experience preferred)
• Familiarity with CLIA laboratory workflows and assay implementation in a production setting Demonstrated
• experience leading projects and collaborating cross-functionally; prior people management experience preferred •
• Experience with high-throughput workflows or automation is a plus
• Technical expertise in oncology diagnostics and NGS technologies
• Understanding of regulatory
• Strong cross-functional collaboration, communication, and interpersonal skills with the ability to build effective working relationships
• Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

Experience

• PhD in Molecular Biology or a related field with 6+ years of industry experience, or BS/MS with 8+ years of relevant biotech industry experience, including at least 2 years of management experience •

Benefits