Full Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
The Program Manager for IVD Development is a key leadership role on the team. Your primary responsibility will be to lead a complex, multi-disciplinary core team to launch IVD products that meet critical unmet needs for cancer patients.
You will lead a cross functional core team in the development of an in vitro diagnostic NGS assay, ensuring delivery of the product through launch while ensuring compliance with our quality system deliverables and regulatory requirements. Experience with IVD or Medical Device product development will be critical to the success of this role. This position will primarily focus on supporting Guardant Health’s projects in the AMEA (Asia, Middle East, and Africa) regions.
You will be responsible for setting up and kicking off projects, aligning with the internal and external teams, and overseeing the execution of clinical studies that support a future IVD submission.
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
Communicate program updates to the core team, to functional management and to executive leadership
Manage joint project team meetings with external partners
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
Maintain project management best practices
Execute initiatives from the Project Management Office
Define program resource needs, negotiate program resourcing plans and track resource usage over the course of the program
Perform other related duties and assignments as required
Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, time and cost reporting is required.
Experience working in FDA-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 SOX compliance is desired
Experience with both Agile and Waterfall program management
PMP or similar certification is highly desired.
Bachelor’s degree in a business or a technical discipline PLUS 4 to 7 years relevant experience OR a Master's degree with 3-5 years relevant experience.
An advanced degree in either business or a technical field is desired. Specific IVD experience can supplement years of experience and education requirements
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
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