About Fulgent
Founded in 2011, Fulgent has evolved into a premier, full-service genomic testing company built around a foundational technology platform.
Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.
Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.
Summary of Position
The Lab Director is responsible for directing the overall function of the Fulgent Curation Department, including direct supervision of employees, sign out of somatic molecular genetics test results, and leadership in research & development. This position requires management skills that allow direct and indirect supervision of the curation scientist team to ensure our continuous quality, integrity, and efficiency of the curation process. Must be familiar and experienced in CAP, CLIA, and State and Federal regulations and certification standards and be responsible for ensuring full compliance of governing regulations. Due to the nature of our current test menu, significant experience with Somatic Next Generation Sequencing (NGS) in solid tumor profiling and/or heme NGS panels are required.
Key Job Elements
- Final report sign-out of our patient reports.
- Provide leadership to the Operations, R&D, and Product Development teams in the areas of clinical and analytical validity.
- Lead curation team to work with research scientists and bioinformaticians on product development efforts.
- Collaborate with the software engineering team to design, optimize, and automate QC and data review interfaces.
- Design assay validation studies.
- Partner with quality management team to develop, implement and maintain SOPs and appropriate quality control and regulatory compliance programs.
- Work with technical supervisors to improve procedures for sequencing QC and data review, review sequencing quality indicators on a weekly basis, and help develop action plans.
- Refine curation protocols and classification criteria.
- Review variant classifications and final reports.
- Function as a knowledge resource for difficult cases.
- Develop new products in conjunction with the Genetic Counseling, Business Development, Sales, and Marketing teams.
- Assist with research, development, and grant applications with various teams including Business Development, Sequencing as a Service, and Research & Development.
- Be an ambassador to the genetics community, including giving public lectures, attending major conferences, and interacting with client providers such as physicians and Genetic Counselors.
- Author/co-author peer-reviewed scientific manuscripts.
- Other tasks as assigned.
