Associate Director, Bioinformatics Development

The Position:

We are seeking a highly experienced and motivated Associate Director, Bioinformatics Development to lead the bioinformatics strategy, design, and development of next‑generation minimal residual disease (MRD) laboratory‑developed tests (LDTs). This role involves technical leadership and mentorship of computational development scientists as well as cross‑program coordination, based on deep hands‑on expertise in NGS ctDNA-based oncology assay development.

The Assistant Director will lead bioinformatics strategy across MRD assay programs, partnering closely with wet‑lab, clinical, quality, regulatory, and software teams to ensure delivery of analytically robust, clinically meaningful diagnostics under CAP/CLIA regulations and design control. This role is ideal for a senior scientist who remains deeply technical while beginning to operate at a program‑ and portfolio‑level.

KEY RESPONSIBILITIES:

Scientific & Technical Leadership

• Provide bioinformatics leadership for MRD assay design, development, and optimization across one or more LDT programs, ensuring alignment with scientific, clinical, and business objectives.
• Serve as a senior scientific contributor and reviewer for assay concepts, signal detection strategies, error suppression approaches, and MRD calling methodologies.
• Apply deep expertise in cancer genomics, ctDNA biology, and NGS technologies to guide assay architecture and analytical decision‑making

Assay Development & Validation

• Lead and/or oversee analytical study design and data analysis for assay development and validation, including accuracy, limit of detection, precision, and robustness.
• Guide development, validation, and maintenance of scalable, production‑ready bioinformatics pipelines supporting MRD analysis, QC, and reporting.
• Review and approve analytical approaches, benchmarking studies, and optimization strategies, ensuring scientific rigor and regulatory readiness.
• Ensure compliance with standards (CAP/CLIA, FDA, IVDR) throughout the bioinformatics development lifecycle, including rigorous testing and documentation.

Leadership & Influence

• Provide day‑to‑day scientific mentorship and technical guidance to bioinformatics scientists and senior scientists.
• Support career development of team members through coaching, technical review, and knowledge sharing.