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, Curation is responsible for directing the overall function of the Fulgent Curation Department, including direct supervision of employees, sign-out of 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 and 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 with governing regulations. Due to the nature of our current test menu, significant experience with Next Generation Sequencing in the context of molecular diagnostics is 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 the 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.

Knowledge / Experience

• Have earned a Ph.D. degree in molecular biology, genetics, or a related field or an M.D. with residency in Anatomic and/or Clinical Pathology (USA/Canada). Sufficient previous work history in the listed fields may substitute educational requirements.
• ABMGG board-certified clinical molecular geneticist or ABP board-certified molecular genetic pathologist.
• Required Experience with: (1) Interpreting variants in the context of the medical literature (experience with germline diagnostics including hereditary cancer syndromes or exome sequencing desired), (2) Corresponding with medical geneticists and oncologists on the interpretation of results, (3) Design of gene panels and molecular tests, (4) Reviewing results of germline and/or somatic NGS assays for validity, (5) CLIA lab operations and testing requirements.
• Comfortable in a fast-paced, dynamic team environment.
• Excellent leadership, human relations, and communication skills.
• Requires high attention to detail and the ability to multi-task and adapt rapidly to changing priorities and tasks.

Supervisory Responsibilities

• Yes

Reports To

• Managing Lab Director

Environment

Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

For California residents, please see the link below to access our CCPA Privacy Notice.

CCPA Privacy Notice for California Residents

https://tinyurl.com/FulgentCCPA