Sr. Project Manager, Clinical Diagnostics Development

Sr. Project Manager, Clinical Diagnostics Development About The Role

The Senior Project Manager, Clinical Diagnostics Development will lead the planning, execution, and control of critical, high-impact projects required to establish and sustain 10x Genomics' clinical diagnostics program and successfully transition novel single-cell and spatial diagnostic assays into a compliant clinical environment. This role ensures complex, cross-functional initiatives—including LIMS integration, QMS establishment, and analytical validation—are completed on time, on budget, and in strict adherence to CLIA, CAP, and other relevant regulatory standards.

• Support the planning and execution of technical transfer and analytical validation projects for new single-cell and spatial assays from assay development teams into the CLIA Laboratory, ensuring full traceability and documentation for verification/validation and that all regulatory requirements are met prior to go-live.
• Develop and maintain detailed project schedules, resource plans, risk registers and work breakdown structures in partnership with 10x internal teams.
• Conduct thorough risk assessments and develop comprehensive mitigation strategies for all assigned projects, particularly those impacting quality and regulatory standing.
• Manage change control processes, scope creep, and schedule deviations, proactively communicating potential impact to stakeholders and proposing mitigation strategies.
• Ensure rigorous documentation and record-keeping throughout the project life cycle.

• Collaborate with the quality team to drive the project plans for QMS establishment, ensuring all project documentation (e.g., facility documentation, equipment qualification, process SOPs) aligns with CLIA/CAP requirements and is audit-ready.
• Collaborate with the information technology team to drive project plans for LIMS and the compute infrastructure required for clinical operations.
• Facilitate the accreditation roadmap, scheduling and tracking deliverables required for CAP inspections, CLIA certification, and specific state approvals (e.g., New York State permit readiness).
• Partner closely with Quality and Regulatory teams to ensure that project milestones incorporate necessary controls and compliance steps.

• Serve as the primary project communication hub, ensuring clear, consistent, and timely reporting of project status, milestones, risks, and dependencies to the project teams and executive stakeholders.
• Organize and lead recurring project review meetings with cross-functional teams, including Laboratory Operations, Assay Development, Clinical Bioinformatics, Quality Assurance, IT, and platform R&D teams to ensure alignment and accountability.
• Foster strong working relationships with technical leads and subject matter experts to accurately capture project requirements and drive decision-making.
• Guide 10x internal teams on project management best practices and principles.

• Advanced degree (Master’s or Ph.D.) in a molecular biology, immunology, bioengineering, or related field.
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Minimum of 7 years of professional experience managing complex projects in a regulated molecular diagnostics or life sciences company.
• Experience managing projects involving molecular diagnostics or Next-Generation Sequencing (NGS) platforms.
• Proficiency with project management tools (e.g., Microsoft Project, Smart Sheet, Jira) and collaboration platforms.

• Project Management Professional (PMP) certification or equivalent qualification (e.g., Lean Six Sigma).
• Strong understanding of regulated diagnostic product development (e.g., CLIA, CAP, ISO 13485 or 21 CFR Part 820) and documentation control.
• Experience with LIMS implementation, integration, or major upgrade projects.

• Strong analytical skills and the ability to translate complex technical requirements into actionable project plans.
• Excellent written and verbal communication skills, capable of effectively…