Sr. Project Manager, Clinical Diagnostics Development at 10x Genomics

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Apr, 26

Salary

204500.0

Posted On

08 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Diagnostics, Regulatory Compliance, Molecular Biology, Analytical Validation, Cross-Functional Collaboration, Quality Assurance, Change Management, Risk Assessment, Documentation Control, Next-Generation Sequencing, LIMS Implementation, Communication Skills, Organizational Skills, Problem-Solving, Team Leadership

Industry

Biotechnology Research

Description

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, 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. Below is the base pay range for this full-time position. The actual base pay will depend on several factors unique to each candidate, including one's skills, qualifications, and experience. At 10x, base pay is also just one component of the Company's total compensation package. This role is also eligible for 10x's equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. During the hiring process, your 10x recruiter can share more about the Company's total compensation package. Pay Range $151,100--$204,500 USD About 10x Genomics At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world. We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience. Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law. 10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.

Responsibilities

The Senior Project Manager will lead the planning, execution, and control of high-impact projects for the clinical diagnostics program. This includes managing technical transfers, ensuring compliance with regulatory standards, and collaborating with cross-functional teams.