Senior Program Manager
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Job Location:
Palo Alto, CA - USA
Monthly Salary:
$ 159660 - 219555
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Company Description
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012 Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care including screening to find cancer early monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information visitand follow the company onLinkedInX (Twitter)andFacebook.
Company Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally throughuseof its proprietary tests vast datasetsand 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 Guardant360TissueNext Guardant360 Response andGuardantOMNI 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 New ProductDevelopmentwill play a critical leadership role in bringingcutting-edgecancer diagnostics to market. This individual will lead cross-functional teams to develop and launch next-generation sequencing (NGS)based products across Research Use Only (RUO) Laboratory Developed Tests (LDT) and In Vitro Diagnostics (IVD) applicationsdirectlyimpactingpatients with unmet clinical needs.
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 Healths qualitysystem deliverablesand regulatory with IVD or Medical Device product development will be critical to the success of this end-to-end product development with complex systems isa must.
You will work closely with key stakeholders across the organization including marketing regulatory quality medical affairs reagent development and bioinformatics teams among others.
Essential Duties and Responsibilities:
Program Leadership & Execution
Drive end-to-end program execution for NGS assay development from concept through commercialization
Align cross-functional stakeholders (R&D Operations Quality Regulatory Marketing Medical Affairs) on priorities timelines and deliverables
Manage program plans timelines resources and dependencies across multiple sub-projects
Stakeholder & Partner Management
Partner with internal leadership and executive stakeholders to provide program updates and drive decision-making
Lead collaboration with external partners to ensure delivery against contractual milestones
Risk & Quality Management
Identify assess and mitigate program risks; drive issue resolution and root cause analysis
Ensuretimelycompletion of design history file (DHF) documentation and compliance with quality and regulatory requirements
Prepare teams for phase gate reviews and key go/no-go decisions
Communication & Reporting
Provide clear concise program updates to core teams and executive leadership
Establish effective communication frameworks across cross-functional teams
Navigate ambiguity and evolving priorities in a fast-paced environmentdemonstratingflexibility and sound judgment to adapt plans and drive programs forward
Basic Qualifications:
Bachelors degree in a technical or business-related field
58 years of program or project management experience (or 35 years with amastersdegree)
Experience in FDA-regulated environments
Demonstrated success leading cross-functional teams in product development
Experience managing complex systems with multiple interdependent workstreams
Preferred Qualifications:
Experience in IVD medical devices or diagnostics product development
Experience with NGS assay development
PMP or equivalent certification
Familiarity with both Agile and Waterfall methodologies
Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has 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. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.
Employee may be required to lift routine office supplies and use office 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 to sit for extended periods of time.
Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities long-term conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to
A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
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.
To learn more about the information collected when you apply for a position at Guardant Health Inc. and how it is used please review ourPrivacy Notice for Job Applicants.
Please visit our career page at: Experience:
Manager
About Company
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 cl ... View more
