Director, Clinical Verification and Validation

Thermo Fisher Scientific Austin, TX

About the Job

Director of Verification and Validation

When you're part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

As Director of Clinical Verification and Validation for the Genetic Testing Solutions Group in Thermo Fisher Scientific, you will be responsible for building the V&V function for the clinical group focused on infectious diseases and oncology. You will be managing teams of scientists to develop and commercialize clinical molecular diagnostic assay products on Thermo Fisher Scientific sample to answer platforms. The Director of Verification and Validation will hire and form a group as well as coordinate V&V activities across multiple groups globally.

What will you do?

  • Have a deep understanding of product design, development and commercialization for life science and/or genetic analysis platforms, content and associated chemistry. Demonstrated success in the commercialization of clinical molecular diagnostic products with an innate ability to drive success through risk awareness and quality through practical process improvements.
  • Possess a strong understanding of our customers and their methods to ensure robust and accurate validation strategies.
  • Work with the team for requirements generation, system integration, building design history, failure modes and effects, test planning for research and clinical systems/applications, design and execution of highly complex test strategies, excellent documentation practice with an unparalleled attention to detail and advanced statistical skills.
  • Highly developed communication skills with the ability to translate complex information to staff, management and cross functional stakeholders.
  • Be an ambassador for the V&V Center of Excellence with an ability to communicate efficiently with groups located across the US and APAC. Strong track record in communicating with FDA and notified bodies to distill requirements and mitigate commercialization
  • Drive Practical Process Improvement: Systematic and process driven with a track record of fostering PPI to improve efficiency and drive excellence. A visible energy and passion for PPI with an ability to enthuse others about its benefits.
  • Builds a great team and great culture to attract, engage, and retain top talent. Develops and builds V&V leadership, technical capability and bench strength at all levels. Decisive leader with the ability to instill individuals with the key requirements to succeed in the dynamic environment of product development and V&V.
  • Strong collaborator with ability to motivate and drive product design excellence across internal cross-functional teams.

How will you get here? Education/Experience:

  • Typically requires a Systems Engineering background or a Ph.D. degree in Biochemistry, Microbiology, Molecular Biology, or related field. Exceptional individuals with master’s degree and extensive experience will also be considered.
  • Minimum of (15+) years of experience in medical diagnostic product development, with (5+) years managing scientific teams as an V&V Manager/Director.
  • Significant contribution to the successful clearance of an FDA regulated medical device.
  • Extensive experience designing & developing nucleic acid-based "sample to answer" molecular diagnostic products within a regulated environment, utilizing design control process required.
  • Experience migrating IVD assays to novel instrument platforms
  • The ideal candidate will have expertise in genomics and molecular biology, including principles qPCR