Senior Bioinformatics Scientist

The Position:

We are seeking a highly experienced and motivated Senior Bioinformatics Scientist to drive the design, and development of next‑generation minimal residual disease (MRD) laboratory‑developed tests (LDTs). This senior, independent scientist position is responsible for contributing to assay concepts, driving analytical development and validation, and partnering closely with wet‑lab, clinical, quality, regulatory, and software teams to deliver robust, clinically actionable MRD diagnostics for multiple indications.

The ideal candidate brings expertise in NGS‑based oncology assays, strong understanding of ctDNA biology and a proven track record of industry assay development under design control. This individual will lead technical execution of key scientific efforts, owning assay bioinformatics from concept through analytical validation and launch.

KEY RESPONSIBILITIES:

Scientific & Technical Expertise

• Contribute to bioinformatics strategy for MRD assay design, development, optimization, and lifecycle management for LDTs developed under CAP/CLIA quality systems.
• Lead and contribute to study design, data analysis, performance characterization, and decision‑making throughout development.
• Apply deep domain knowledge in cancer genomics, ctDNA biology, and NGS technologies to inform assay architecture, variant detection strategies, and error suppression approaches in collaboration with our data science and modeling teams.

Assay Development & Validation

• Design and execute analytical studies to evaluate assay performance, including accuracy, limit of detection, and reproducibility, in collaboration with wet‑lab and biostatistics partners.
• Develop, validate, and maintain scalable, production‑ready bioinformatics pipelines for MRD analysis, including QC, variant calling, MRD calling logic, and reporting.
• Lead benchmarking and optimization of computational methods, including background error modeling, and longitudinal MRD tracking.
• Ensure compliance with standards (CAP/CLIA, FDA, IVDR) throughout the bioinformatics development lifecycle, including rigorous testing and documentation.

Cross‑Functional Collaboration

• Partner closely with molecular biology, assay development, QA/RA, clinical, and software engineering teams to ensure bioinformatics solutions are aligned with assay design, regulatory expectations, and operational constraints.
• Contribute to regulatory submissions and audits by providing technical documentation and validation report, and responses to audits or regulatory inquiries.

Mentorship & Influence

• Provide technical mentorship and scientific guidance to junior scientists, helping raise the overall bar of assay development rigor and execution.
• Communicate complex analytical concepts and results clearly to both computational and non‑computational stakeholders, including senior leadership.

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