Principal Bioinformatics Scientist

Role: Principal Bioinformatics Scientist leading NGS-based MRD assay development for cancer diagnostics, overseeing bioinformatics strategy, assay design, and validation within regulated CAP/CLIA environments. Responsibilities: drive assay conceptualization, analytical validation, and perform study design and performance characterization; develop and maintain production pipelines; collaborate with wet-lab, clinical, quality, regulatory, and software teams; contribute to regulatory documentation; mentor junior staff; communicate complex data to diverse stakeholders. Requirements: Ph.D. in Bioinformatics, Genomics, or related field; 8+ years industry experience, including at least 5 years in regulated healthcare or diagnostics; extensive hands-on expertise in ctDNA biology, NGS assay development, and clinical assay validation; strong programming in Python, familiarity with SDLC best practices; experience in regulated environments (CAP/CLIA, IVD). Preferred: management experience, AWS workflow deployment, germline and somatic mutation knowledge, R proficiency, database skills. High-Value: oncology focus, ctDNA, MRD assays, assay validation, regulated diagnostics, cross-functional collaboration, leadership in scientific and technical domains. Work setup: based in San Diego or South San Francisco, with salary ranges $184K–$210K depending on location and experience.