Sr Director/Director NGS Assay Development - #2055

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.

GRAIL, Inc., is developing differentiated platforms for the early detection of cancer. These platforms combine approaches to ultradeep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL's software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer. 

In this role, you will build and manage a team at the forefront of NGS assay R&D to create the assay platforms to meet GRAIL's research and product goals. Working cross-functionally with computational, software, clinical and operational groups you will execute critical R&D projects. You will be an author and champion of GRAIL's R&D processes and advocate of GRAIL's scientific culture of rigor. 
You will...

• Oversee GRAIL’s assay development team with responsibilities spanning product development and operations support
• Define and execute a strategy to deliver robust and scalable assay and processes to support GRAIL’s various product opportunities
• Also oversee a team responsible for R&D lab management to ensure safe, compliant and highly functioning R&D lab operations
• Set team goals, manage budgets, allocate resources, and empowering team members to drive delivery across a breadth of programs  
• Develop and lead a growing team of assay and process scientists with the diverse scientific and technical skills required to execute projects
• Establish and propagate best practices and processes for NGS assay developmentPartner closely with other team leaders including automation engineering, computational, statistics, quality, regulatory, and operations to collaboratively advance programs and resolve issues
• Motivate and mentor employees both within and outside their teamsPromulgate a culture of scientific curiosity and rigor, collaboration, and respect 

Your background should include...

• 7+ years of industry experience in a diagnostic, medical device, life science tools, or biopharma settingPh.D. in Molecular Biology, Biochemistry, Chemistry, or related scientific disciplineDeep technical knowledge of biochemistry and molecular biology, particularly as applied to NGS-based assay, demonstrated by publications or patents
• Proven track record of developing assay and scaled processes for regulated life sciences products (e.g., 510(k)K or PMA)
• Working knowledge of FDA 21 CFR Part 820, IVDD/IVDR, ISO 13485 as applied to assay developmentProven track record of building and leading a successful assay development teamExcellent oral and written communication skills 

PREFERRED BACKGROUND

• Experience with assay process engineeringExperience with assay automationWorking knowledge of statistical approaches applied to product developmentWorking knowledge of data analysis and tools applicable to NGS assay We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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.