Senior Program Manager (NGS Assay Development)

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 Senior Program Manager for new product development is a key leadership role on the team.   Your primary responsibility will be to lead a complex, multi-disciplinary core team to launch products for Research Use Only (RUO), Lab Develop Tests (LDT), and In Vitro Diagnostics (IVD) that meet critical unmet needs for cancer patients.

You will lead a cross-functional core team in the development of an NGS assay, ensuring delivery of the product through launch while ensuring compliance with Guardant Health’s quality system deliverables and regulatory requirements.   Experience with IVD or Medical Device product development will be critical to the success of this role.  Successful end-to-end product development with complex systems is a must.

You will work closely with key stakeholders across the organization, including marketing, regulatory, quality, medical affairs, reagent development, and bioinformatics teams, among others. In addition, you will lead the joint project team with our external partners.

Essential Duties and Responsibilities:

• Lead a cross-functional product development 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
• Lead a cross-functional joint project team with external partners to align and execute the project per contractual milestones
• Communicate program updates to the core team, to functional management, and executive leadership both internally and externally
• 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, monitoring, and reporting
• 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 throughout the program
• Perform other related duties and assignments as required
• Manage leadership stakeholders and present at executive management forums

Qualifications

• Bachelors degree in a business or a technical discipline. An advanced degree in either a business or a technical field is desired. Relevant experience of 5 to 8 years with BS/BA and 3-5 years with a Masters degree in addition to meeting the experience requirements
• PMP or similar certification is highly desired
• Experience working in team environments is required.
• Expert-level knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, and time and cost reporting is required.
• Experience working in FDA-regulated environments is required
• Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired
• Specific experience managing complex system programs with multiple sub-projects as part of a complete solution is required
• Experience in product development for NGS assays is required
• 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 is preferred.

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 alig