Associate Director, Portfolio Program Management, Screening

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. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

The Associate Director, Portfolio Program Management is a key leadership role on the team. Your primary responsibility will be to lead a complex, multi-disciplinary core team to launch 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.

You will work closely with key stakeholders across the organization, including marketing, regulatory, medical affairs, reagent development and bioinformatics teams, among others. You will also work very closely with the portfolio team to align program scope, resources and budget within the portfolio prioritization process. You will be responsible for ensuring future product enhancements/modifications are staffed and executed with respect to the overall portfolio.

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, potentially with external partners, to align and execute the project per contractual milestones
• Communicate program updates to the core team, to functional management and to executive leadership both internally and externally, if applicable
• 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
• Incorporate the product roadmap into the portfolio process and execute the programs accordingly
• Perform other related duties and assignments as required

• Bachelor’s 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 master’s degree
  PMP or similar certification is highly desired
• 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 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

Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.

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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Please visit our career page at: http://www.guardanthealth.com/jobs/

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