Sr. Director – Bioinformatics Development

Sr. Director – Bioinformatics Development

Requirements

• Ph.D. in Bioinformatics, Computational Biology, Statistics, or related field of study
• Minimum of 10 years post-Ph.D. relevant work experience
• At least 5 years of management experience, supervising scientists at all levels
• Extensive experience in NGS-based LDT diagnostic product development
• Applied knowledge of CAP/CLIA, CLSI, and relevant CFR and ISO guidelines
• 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
• Experience with the principles of production bioinformatics software development
• 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
• Excellent written and verbal communication and presentation skills

Responsibilities

• Oversee the development team within the data science organization
• Coordinate the design, analysis, and documentation of studies required to bring diagnostic products to market
• Oversee the computational Sustaining and Continuous Improvement team
• Ensure activities are executed according to established guidelines (e.g., CLSI, IVDR)
• Document activities according to GCP/GDP requirements
• Set quarterly goals and develop team member’s skills and abilities
• Foster career growth of team members
• Collaborate with other leaders within the R&D organization for strategic planning
• Establish expectations for successful cross-functional collaboration among stakeholders
• Contribute to setting the standard for excellence in diagnostic assay development

Preferred Qualifications

• Specific experience working on IVD/IVDR tests and/or New York State submissions is preferred