The Position:

Veracyte is seeking a talented bioinformatics leader with deep experience in developing and launching regulated diagnostic assays to oversee the development team within our data science organization. In partnership with laboratory leads, the candidate will coordinate the design, analysis, and documentation of studies required to bring life-saving diagnostic products to market. They will also oversee the computational Sustaining and Continuous Improvement team that focuses on maintaining and improving our existing clinical offerings.

Location: This is a hybrid position based in our San Diego or South San Francisco office.

• Working within CAP/CLIA- and IVD-regulated environments, the successful candidate will apply their expertise in NGS-based assays to oversee the development of robust bioinformatic pipelines, classification algorithms, and quality-control metrics that will be validated and productionized in collaboration with our software development teams. The candidate will ensure that such activities are executed according to established guidelines (e.g., CLSI, IVDR), and documented according to GCP/GDP requirements.
• As a strong team lead, the candidate will work in close collaboration with the managers and individual contributors within their organization to set quarterly goals, develop team member’s skills and abilities, and foster their career growth. In collaboration with other leaders within the R&D organization, the computational lead will be responsible for strategic planning to meet Veracyte’s development goals, as well as establishing expectations for successful cross-functional collaboration among company-wide stakeholders.
• As a key functional leader, working in a collaborative and fast-paced environment, the individual will contribute to setting the standard for excellence in diagnostic assay development, swiftly implementing their team’s efforts into products that transform patient lives.

Who You Are:

• Ph.D. in Bioinformatics, Computational Biology, Statistics, or related field of study. Minimum of 10 years post-Ph.D. relevant work experience, with at least 5 years of management experience, supervising scientists at all levels.
• Extensive experience in NGS-based LDT diagnostic product development, with applied knowledge of CAP/CLIA, CLSI, and relevant CFR and ISO guidelines, including taking products through development, validation, and launch. Specific experience working on IVD/IVDR tests and/or New York State submissions is preferred.
• Deep knowledge of core principles of molecular biology surrounding NGS-based diagnostics with a demonstrated ability to tie the results of the team’s analysis back to specific assay steps.
• Experience with the principles of production bioinformatics software development, including coding best-practices, software testing, and validation.
• Strong analytical skills and proficiency in programming languages such as R, and/or Python. Comfort working in cloud computing environments (AWS preferred).
• Experience writing and coordinating development documentation in a cross-functional capacity, including development plans and reports, as well as software-related documentation such as requirements and development specifications.
• Excellent written and verbal communication and presentation skills are required.

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