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 Director of Data Integrity, will ensure the integrity of all GRAIL clinical research data. The Director of data integrity, will ensure that data generated from GRAIL’s global clinical studies meet ALCOA+ principles for data integrity to ensure usability and reliability. You will also support regulatory submissions and inspections, good-clinical-practice (GCP) counseling, and training. 

You will:

• Serve as a leader in GRAIL’s Clinical Compliance Department
• Provide global strategic and operational mentorship on data integrity standards.
• Lead the development and implementation of a robust Data Integrity Program across GRAIL’s global clinical studies
• Support regulatory submissions and regulatory inspections related to clinical data
• Represent Clinical Compliance Department across governance and strategic committees
• Incorporate data integrity training, and standards in all GxP environments and functional area policies and procedures
• Advise on computer system validation requirements and standard methodologies (GAMP, 21 CFR Part 11)
• Conduct data integrity assessments and audits, and lead response planning

Your background and qualifications will include

• Data integrity experience for a life sciences company (pharmaceutical or medical device experience).
• Specialist in FDA/ICH/GCP principles related to clinical studies
• Extensive knowledge of GxP environments
• Sponsor support of health authority inspections and submission of marketing authorizations
• Significant computer system validation experience
• Global clinical trial expertise and a track record of leading through influence, and working across global organizational matrices
• Bachelor’s degree required. Advanced degree preferred
• At least 15 years of relevant industry experience, with substantial experience of managing staff in a global setting
• Technical expertise in clinical operations

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.