Staff Project Manager
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
This position will be responsible for providing Project Management support to GRAIL’s Ex-US Business Program efforts, in particular ex-US Regulatory and Quality work, ensuring all project milestones and deliverables are met and that activities are well executed and managed. Project management responsibilities include the management of the day-to-day cross functional task tracking as well as longer term planning. The successful candidate will partner with the applicable Business Program Teams, identifying and managing key risks, dependencies and metrics that optimize the team’s effectiveness and decision making, facilitate team building and communication, create and drive timelines and collaborate with Program Management (“PMO”) Leadership and colleagues to define program-related budget assumptions for annual and long-range operating plans.
You Will:
- 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
- Facilitate communication of working group issues & outcomes to the Program team leadership
- 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 to prepare status reports, specific project updates, and scenarios.
- Coordinate resources, timelines, and deliverables with other business project managers.
Your Background Includes:
- A minimum of a BA/BS in a scientific field is required, while an advanced degree (PhD, MS, MBA, MD) is desirable in a discipline related to device, diagnostic, and/or drug development.
- 10+ years multi-disciplinary experience in the device/diagnostic/biotech industry, with 3-5 years of direct project management experience on interdisciplinary or cross functional product development teams. Project Management Certification (PMP or equivalent) is a plus.
- Experience working under design control.
- Understanding of and experience in managing ex-US Regulatory and Quality requirements for the development and commercialization of medical devices or diagnostics, e.g., CE mark, IVDD/IVDR.
- Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
- Proactive individual with strong leadership, facilitation, teamwork, and influence management/negotiation as well as excellent organizational skills.
- Proven ability to proactively identify risks and drive resolution of issues.
- Ability to work independently for decision-making and resolution of project obstacles and conflicts.
- Ability to drive project plans and timelines (across multiple functional areas) is essential.
- Excellent communication skills (in person and written word) and ability to interact with a diverse group of individuals.
- Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics.Participation in an executive steering committee for product development.
- Results and detail-oriented; self-motivated, ability to work with minimal supervision.
- Ability to perform and be adaptive in a fast-paced environment under tight deadlines.
- Proven success in goal setting, prioritization, and time management.
- Oncology experience.
Preferred:
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.