Sr. Project Manager, Clinical Diagnostics Development

10x Genomics•Pleasanton, CA

About The Position

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.

Requirements

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.

Nice To Haves

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 interacting with scientific, technical, and executive audiences.
Exceptional organizational skills, attention to detail, and a structured approach to problem-solving.
Proven ability to lead and manage cross-functional teams without direct reporting authority.
Proficiency in change management principles.
Driven, thoughtful, and ambitious, with a high sense of ownership and urgency to build new, high-quality, and compliant capabilities.

Responsibilities

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.