Project Manager, CDx

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Project Manager is a part of the Program Management Office (PMO). Your primary responsibility will be to drive projects within the overall complex, multi-disciplinary programs and lead core and sub-teams for the projects. You will lead and participate in supporting the overall program, maintaining timelines and schedules for the projects, supporting cross-functional activities and document management needs for the program.

You will be accountable for managing resources, schedules, and financials and adhering to stage gate quality and SDLC control guidelines throughout the full systems development life cycle. This also includes management of issues, risks, and project change requests to ensure successful and on-time project delivery. You will also contribute to process improvement initiatives as it relates to improving project delivery.

Responsibilities: 

• Lead a cross-functional core team in the execution of deliverables.  Work closely with R&D, Operations, Quality, Marketing, Regulatory, Medical Affairs, and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans
• Understand interdependencies between technology, operations, and business needs
• Manage multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence
• Communicate program updates to the core team, to functional management and executive leadership
• Ensure timely team completion of documents required for the product design history file
• Lead team efforts to mitigate risks and resolve issues quickly as they arise
• Lead the team 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
• Lead the program planning process
• Ensure effective communications with the Core Teams using a variety of tools and channels
• Define program resource needs, negotiate program resourcing plans, and track resource usage over the course of the program
• Participate in establishing practices, templates, policies, tools and partnerships to expand and mature these capabilities for the organization
• Perform other related duties and assignments as required

Qualifications

• Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, and time and cost reporting is required.
• Experience working in regulated environments or clinical studies is required
• Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired
• Position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the various issues to result in a successful product launch
• Experience with both Agile and Waterfall program management, PMP certification preferred

Education:

• Bachelors degree in a business or a technical discipline. 
• An advanced degree in either business or a technical field would be a plus.
• Relevant experience of 2 to 3 years with BS/BA and 1-3 years with Masters degree
• PMP or similar certification would be a plus.

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires.