Associate Director, Bioinformatics Development

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.
• Communicate complex analytical concepts clearly to stakeholders at varying levels of technical depth, including senior leadership.

REQUIRED EXPERIENCE:

• Ph.D. in Bioinformatics, Computational Biology, Genomics, Biostatistics, or a closely related quantitative field.
• Minimum 8 years of total relevant experience, with at least 5 years of management experience in biotech, diagnostics, or regulated healthcare environments.
• Demonstrated experience leading NGS‑based assay development for clinical diagnostics. Hands‑on experience with ctDNA‑based MRD assays, including personalized or tumor‑informed approaches.
• Strong programming skills in Python, with experience developing and benchmarking reproducible, production‑grade analysis pipelines, including experience with SDLC best practices.
• Proven experience working in design‑controlled, regulated environments (CAP/CLIA LDT, IVD, or equivalent) is a must.
• Track record of working with wet lab scientists on iterative experiment design, execution, analysis, and interpretation as a tightly integrated team.
• Demonstrated record of technical and scientific leadership, ownership, and independent work.

PREFERRED EXPERIENCE:

• Experience developing and deploying bioinformatics workflows in AWS (e.g., EC2, S3, Step Functions, Batch, Lambda, etc.).
• Strong understanding of germline and somatic mutation processes leading to complex variation and genome-wide biomarkers with potential clinical utility.
• Working knowledge of R.
• Experience with relational and non-relational database technologies is a plus.

#LI-Onsite, #LI-Hybrid, or #LI-Remote

For candidates based in our San Diego office, the salary (or hourly range is $202,000- $219,000.

For candidates based in our South San Francisco office, the salary or hourly range is $220,000 - $231,000.

For candidates working remote (US), the salary or hourly range is $192,000 - $208,000.