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.

This position will provide project management expertise and support to one of GRAIL’s product lifecycle teams, ensuring all project milestones and deliverables are met and that activities are well executed and managed. The successful candidate will partner with the Team Leader to optimize the team’s effectiveness and decision making, facilitate team building and communication, build and drive timelines to keep project(s) on schedule and collaborate with Program Management (“PMO”) Leadership.

You will:

• Work closely with key stakeholders across the organization, including marketing, regulatory, quality, medical affairs, lab operations, clinical development and bioinformatics teams, among others, to prepare status reports, specific project updates, and scenarios.
• Establish and maintain functionally integrated project schedules and other tracking tools to enable accurate project management across various functional areas
• Schedule, organize, and drive team meeting(s): prepare and distribute agendas/minutes; track action items, and escalate areas of concern to the appropriate management entity
• Adhere to design control best practices and engage with functional leads to generate expected documentation throughout product development
• Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important project milestones. This includes regular interactions with functional heads for resource management.
• Interact with working group leads and/or SMEs Lead team efforts to mitigate risks and resolve issues quickly as they arise through problem resolution including root cause analysis and corrective action
• Lead the team to prepare for design reviews, phase gates and other go/no go decisions required by executive leadership

Your background should include:

• Minimum of a BA/BS in a scientific field is required, while an advanced degree is desirable in a subject area related to device, diagnostic, and/or drug development.
• The ideal candidate will have at least 10 years multi-disciplinary experience in the device/diagnostic (strongly preferred)/biotech industry, with 3-5 years of direct project management experience on interdisciplinary or cross functional product development teams.
• Extensive experience working under and managing projects through design control.
• Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics.

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.