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Form of workGuardant 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.
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 a NGS assays, 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 to 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 over the course of the program
- Perform other related duties and assignments as required
- Manage leadership stakeholders and present at executive management forums
- 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 a minimum of 5 years' experience of related experience with BS/BA OR a minimum of 3 of years with Master's degree in addition to meeting the experience requirements
- Required working within Biotechnology, Pharmaceutical or Medical Device industry a minimum of 4 years.
- 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, 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 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 is required
Work Environment:
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.
Hybrid work environment. Can be negotiated.
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 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.
The US base salary range for this full-time position is $94,080 to $145,600. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).
For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $134,400 to $182,000. The range does not include benefits, and if applicable, bonus, commission, or equity.
Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.
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 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 [email protected]
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 our Privacy Notice for Job Applicants.
Please visit our career page at: http://www.guardanthealth.com/jobs/
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