Director/Sr Director, Project Management - PDx Team

Employer
GRAIL, Inc.
Location
Menlo Park, CA
Posted
Oct 08, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 is a key leadership role created to help establish and manage a new business unit through one of GRAIL’s Lifecycle Teams. Your primary responsibility will be to oversee a complex, multi-disciplinary team to develop and launch a portfolio of IVD products, with external biopharma collaboration partners.   You will also establish effective project management business processes for this new business unit that integrate with the broader GRAIL corporate processes.

This Program is focused on co-development with outside (domestic and international) collaborators through Joint Project Team(s) managing the clinical development plan aspects of the life cycle plan while internally developing an in vitro diagnostic NGS assay. The successful candidate will partner with the Team Leader and General Manager to optimize this business unit’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 and required for this role. This role may have 1 or more reports, 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 10 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 5 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.

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.

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.