Sr. Manager, Diagnostic Assay Development

10x Genomics•Pleasanton, CA

30d

About The Position

The Director of Diagnostic Assay Development, reporting to the VP, Clinical Applications, will lead the design, prototyping, and validation of laboratory developed tests (LDTs) based on 10x single-cell and spatial assay technologies. The ideal candidate has led clinical assay development in a diagnostic company operating a CLIA lab, has deep technical experience with advanced molecular and cellular profiling technologies (NGS, single-cell, spatial), and thrives in a hands-on leadership role managing a small R&D lab team while engaging with senior management, collaborators, and external partners.

Requirements

PhD in molecular biology, immunology, bioengineering, or related field.
Minimum of 10 years' experience in clinical assay development, including 5 or more in a leadership role within a regulated diagnostics environment.
Proven success developing and validating complex molecular assays (e.g., NGS, single-cell, spatial transcriptomics, multiplex imaging).
Demonstrated ability and enthusiasm to lead assay design, troubleshooting, and validation hands-on at the bench.
Experience collaborating across research, development, and clinical teams.
Familiarity with analytical validation requirements and CAP/CLIA standards

Nice To Haves

Technically strong, detail-oriented, and driven by scientific rigor.
Driven, thoughtful, and ambitious, with a high sense of ownership and urgency.
Comfortable working at multiple levels—from day-to-day lab management to strategic planning and partner engagement.
Motivated by building something new and impactful in the diagnostic space.

Responsibilities

Design, prototype, troubleshoot, and optimize single-cell and spatial assays for clinical application.
Develop and document robust assay workflows suitable for transfer into CLIA environments.
Plan and oversee analytical validation studies, including accuracy, precision, sensitivity, specificity, reproducibility, and robustness testing.
Lead method development for automation, throughput, and quality improvements.
Direct laboratory execution of large-scale clinical research studies, including partnerships with leading academic centers processing thousands of tumor and blood samples.
Work with external collaborators to generate and interpret data that demonstrate clinical validity and utility.'
Coordinate with bioinformatics and translational teams to align assay development with biomarker discovery and clinical readout requirements.
Act as the primary technical resource for the CLIA operations team.
Collaborate with 10x platform and product teams to translate emerging technologies into clinically deployable assays.
Manage and mentor a small team of scientists and research associates in a hands-on laboratory environment.
Represent the diagnostic assay development function to internal leadership and external partners, providing clear communication of technical plans, progress, and results.
Contribute to scientific manuscripts and presentations at major conferences.
Build and maintain processes that ensure scientific rigor, regulatory readiness, and operational scalability.
Help establish the laboratory infrastructure, quality systems, and best practices needed for clinical assay development.
Contribute to the diagnostic strategy and roadmap for 10xDx.