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.
About the Role:
The Portfolio Program Manager is a key leadership role on the team and part of the Program Management Office (PMO). Your primary responsibility will be to lead complex, multi-disciplinary core teams to launch products that meet critical unmet needs for cancer patients around the world.
You will lead cross functional core teams in the development and deployment of diagnostic NGS assays, ensuring delivery of the product through launch while ensuring compliance with our quality system deliverables and regulatory requirements. Experience with IVD, CE-IVD, or Medical Device product development will be critical to the success of this role.
You will be responsible for setting up and kicking off projects, aligning with the internal teams, and overseeing the execution of the programs. In many cases, you will also be interacting with external partners and regulatory authorities. A main focus of this role will be to launch international products.
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
Communicate program updates to the core team, to functional management and to 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
Perform other related duties and assignments as required
Experience working in team environments is required. Knowledge of Program or Project Management tools such as: project scheduling, work breakdown structures, 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
Bachelors degree in a business or a technical discipline. An advanced degree in either business or a technical field is desired.
Relevant experience of 4 to 7 years with BS/BA and 3-5 years with Masters degree.
PMP or similar certification is highly desired
Employee may frequently exert up to 20-50 pounds of force to push or lift equipment
This position requires standing/walking/crawling regularly
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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