Project Manager, NGS Clinical Diagnostics

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.