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Assoc. Director/Director Project Management - PDx

Employer
GRAIL, LLC
Location
Menlo Park, CA
Start date
Sep 15, 2021

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Discipline
Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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 a key leadership role on one of GRAIL’s Lifecycle Teams. Your primary responsibility will be to manage a complex, multi-disciplinary core team to launch IVD products, possibly with multiple collaboration partners. 

This Program is focused on work with outside (domestic and international) collaborators through Joint Project Team(s) managing the clinical development plan aspects of the life cycle plan specifically developing an in vitro  diagnostic NGS assay. The successful candidate will partner with the Team Leader to optimize the team’s effectiveness and decision making, facilitate team building and communication, create and drive timelines to keep project(s) on schedule and collaborate with Program Management (“PMO”) Leadership.

This leadership role requires a combination of management, analytical, organizational, and interpersonal skills. Experience with IVD/CDx development and managing multinational programs with collaboration partners are critical to this role. This role may have more than 1 direct report, also supporting this program. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
You Will:
  • Work closely with key stakeholders across the organization, including marketing, regulatory, medical affairs, lab operations and bioinformatics teams, among others, to prepare status reports, specific project updates, and scenarios.
  • Manage joint project teams with external partners.
  • 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
  • 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 phase gate reviews and other go/no go decisions required by executive leadership
  • Perform other related duties and assignments as required

Your Background Should Include:
  • Minimum of a BA/BS in a scientific discipline is required, while an advanced degree is desirable in a discipline related to device, diagnostic, and/or drug development.
  • The ideal candidate will have at least 15 years multidisciplinary experience in the device/diagnostic/biotech industry, with at least 5 years of direct project management experience on interdisciplinary or cross functional product development teams focused on clinical development of an in vitro /companion diagnostic, and at least 2 years of direct line management experience. 
  • Project Management Certification (PMP or equivalent) is a plus.
  • Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics
  • Experience working and managing projects under design control.
  • Proactive/not passive: Motivated to solve problems and create/manage situations to move forward while keeping the whole team intact through positive energy.
  • Communication: Can distill complex scenarios/ideas into clear messages and next steps to a broad audience
  • Adaptive: Can pivot quickly to new ideas, direction and process while being grounded in defining what success looks like.
  • "Edge": Comfortable in tough situations, can be relied on in tense circumstances, and will face difficult challenges with poise and self-assurance. For example, comfortable influencing decision-making of others internally, across functions/team, and at any level.

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, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies (“Agency”), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings (“Agreement”).  GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place.  Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement.   Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes.  Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team.

Company

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.

LEADERSHIP:

CEO: Bob Ragusa

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Company info
Website
Phone
833-694-2553
Location
1525 O'Brien Drive
Menlo Park
California
94025
US

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