Project Manager, NGS Clinical Diagnostics

About this role

About the Role We are seeking an experienced Project Manager to lead the development, validation, and commercialization of Next Generation Sequencing (NGS)-based Laboratory Developed Tests (LDTs). This role will coordinate cross-functional teams spanning assay development, bioinformatics, laboratory operations, quality, regulatory, and commercial functions to successfully launch new clinical testing services. The ideal candidate combines strong project management skills with a solid understanding of NGS technologies and molecular diagnostics, enabling them to effectively drive technical programs from concept through clinical launch.

Key Responsibilities Program Leadership Develop and manage integrated project plans, timelines, milestones, and deliverables. Lead cross-functional project teams and drive accountability across stakeholders. Identify project risks, dependencies, and mitigation strategies. Provide regular status updates to leadership and key stakeholders.

NGS and Technical Coordination Coordinate development of NGS-based clinical assays from design through launch. Work closely with scientists, bioinformaticians, and laboratory personnel to ensure successful execution of technical objectives. Understand and track key assay performance metrics, validation requirements, and operational readiness activities. Translate complex technical topics into clear project plans and business updates.

Validation and Clinical Launch Coordinate analytical and clinical validation studies. Ensure alignment of assay development, bioinformatics, quality, and regulatory activities. Drive completion of documentation, SOPs, training, and launch-readiness requirements. Support implementation of new tests into clinical laboratory operations.

Quality and Regulatory Collaboration Partner with Quality and Regulatory teams to support CLIA, CAP, HIPAA, and applicable state compliance requirements. Track validation documentation, change controls, audit readiness, and quality milestones. Ensure compliance requirements are incorporated into project timelines and deliverables.

Commercial and Operational Readiness Coordinate launch activities across operations, business development, marketing, and customer support teams. Support laboratory capacity planning, customer onboarding, and implementation activities. Facilitate communication between technical and commercial stakeholders to ensure successful market adoption.

Qualifications Required BS or MS in Molecular Biology, Genetics, Genomics, Bioinformatics, Biotechnology, Clinical Laboratory Science, or a related field. 5+ years of project or program management experience in molecular diagnostics, genomics, biotechnology, or clinical laboratory environments. Working knowledge of Next Generation Sequencing workflows, including sample preparation, sequencing, bioinformatics analysis, and clinical reporting. Experience leading cross-functional technical projects. Strong communication, organizational, and stakeholder management skills.

Preferred Experience launching NGS-based clinical assays or LDTs. Familiarity with CLIA and CAP laboratory environments. Experience working with Illumina, PacBio, or Oxford Nanopore platforms. PMP certification. Knowledge of bioinformatics pipelines, variant interpretation, and genomic reporting workflows.