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.

The ideal candidate possesses a PMP certification, deep experience in project strategy, and technical familiarity with advanced molecular profiling technologies (NGS, single cell, spatial). They thrive in a hands-on, cross-functional environment, driving accountability across technical and compliance teams.

What you will be doing

Project Planning and Execution (Assay Transfer and CLIA Operations)

• 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

Quality and Compliance Program Support

• 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.

Cross-Functional Collaboration and Communication

• 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.

To be successful, you will need:

• Advanced degree (Master’s or Ph.D.) in a molecular biology, immunology, bioengineering, or related field.
• 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, SmartSheet, Jira) and collaboration platforms.

Additionally, we'd like to see:

• 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.

It would be advantageous if you had:

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