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About the Role
We are seeking a highly experienced and motivated Principal Bioinformatics Scientist to lead the bioinformatics strategy, design, and development of next-generation minimal residual disease (MRD) laboratory-developed tests (LDTs). This role is a senior technical leadership position responsible for shaping 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.
Responsibilities
- Lead bioinformatics strategy for MRD assay design, development, optimization, and lifecycle management for LDTs developed under CAP/CLIA quality systems.
- Serve as the bioinformatics owner, driving 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.
- 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.
- 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.
- Facilitate successful production pipeline deployment by working closely with infrastructure and engineering teams.
- Contribute to regulatory submissions and audits by providing technical documentation and validation report, and responses to audits or regulatory inquiries.
- Mentor junior scientists by providing technical and scientific guidance, 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.
Requirements
- 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 direct industry 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 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).
- Proficiency in development of novel bioinformatics methodologies, and algorithms development, including benchmarking of computational methods.
- 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.
- 1-2 years management experience preferred.
- 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.
Skills
- NGS-based oncology assays
- ctDNA biology
- Python
- SDLC best practices
- CAP/CLIA LDT
- IVD
- AWS
- R
- Relational database technologies
- Non-relational database technologies
Location
- San Diego
- South San Francisco
Work Type
- Hybrid
Experience Level
- Principal
- Senior
Education Level
- Ph.D.
Salary/Compensations
- $184,000 - $204,000 USD
- $190,000 - $210,000 USD
Benefits
- Competitive compensation and benefits
- Significant career opportunities
- Eligible for additional discretionary bonuses/incentives
- Eligible for restricted stock units
About the Company
- Veracyte is a global diagnostics company whose vision is to transform cancer care for patients all over the world.
- We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer.
- Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development.
- For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).
Equal Opportunity
- Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status.
- Veracyte participates in E-Verify in the United States.
- View our CCPA Disclosure Notice