Senior Director / Director Clinical Laboratory Operations
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
The Sr. Director/Director of Clinical Laboratory Operations is responsible for the overall Laboratory Operations at Grail’s Menlo Park, CA (MPK) Site and the supervision of MPK laboratory personnel. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work independently in a team environment. The Sr. Director/Director of Laboratory Operations must also act as a liaison between the laboratory staff and the Product Development, Automation, Research, Bioinformatics, Software Technical Operations and Materials Management groups. The Sr. Director/Director of Laboratory Operations must exhibit leadership skills such as good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal skills, and the ability to effectively communicate across all levels of the laboratory and across departments.
You will:
- Oversee the overall Laboratory Operations at the Menlo Park site including planning, directing and evaluating all clinical laboratory activities within the facility.
- Ensure test systems are functioning properly, monitoring patient and quality control testing results, planning, validation and implementation of new test procedures.
- Collaborate with the CLIA Laboratory Director and Laboratory Managers on the laboratory’s quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training and education programs. Lead and participate on cross functional teams responsible for implementation of new products, process improvements, and troubleshooting activities in the clinical laboratory.
- Ensure stability studies, validation protocols, and other process improvement and new assay projects are implemented per protocol.
- Lead and participate on cross functional teams responsible for maintaining CLIA certification, CAP accreditation, NYCLEP, and state licensure for the GRAIL Clinical Laboratory, including compliance with all applicable standards and regulations.
- Review validation and stability study protocols and technical reports.
- Participate in quality assurance activities.
Your background and qualifications will include:
- California Clinical Laboratory Scientist license.
- Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field.
- 12 +years of Laboratory experience or equivalent. with people management experience and the ability to develop staff.
- Working knowledge of local, state, and federal laboratory regulations.
- Operations and people management experience required.
- Strong project management abilities.
- Strong collaborator and demonstrated track record of success in a cross functional team environment and management roles.
- Strong technical skills in molecular biology and other relevant industry knowledge.
- Strong automation and computing skills.
- Ability to effectively communicate technical information to technical and non-technical audiences.
- Ability to proactively communicate consistently, clearly, and honestly.
- Experience with next generations sequencing (NGS) and sample preparation
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.