Associate Director, Portfolio Program Management

Guardant Health; Palo Alto, Northern (CA, KY); Hybrid; USD 199,000 - 274,000; Full time

Job summary

Guardant Health seeks an Associate Director, Program Manager to lead multi-disciplinary teams in launching RUO, LDT, and IVD products. You will drive development of NGS assays, automation, and infrastructure while ensuring regulatory compliance and quality system deliverables.

You will partner with marketing, regulatory, quality, medical affairs, and bioinformatics to meet milestones and successfully bring complex products to market.

Qualifications

• Bachelors in a business or technical field; advanced degree desired.
• PMP or similar certification highly desired.
• Experience in FDA-regulated environments is required.
• Experience launching medical devices or IVD products is highly desired.
• Experience with complex multi-subproject programs and NGS assays is desired.

Responsibilities

• Lead cross-functional product development core team to deliver on milestones.
• Coordinate with R&D, Operations, Quality, Regulatory and Marketing to align priorities.
• Lead joint projects with external partners and manage contractual milestones.
• Communicate program updates to leadership and stakeholders.
• Prepare documentation for design history files and phase gate reviews.

Skills

Project management

Cross-functional leadership

FDA-regulated

Agile & Waterfall

R&D collaboration

Education

BS/BA in business or technical

MS/MA in business or technical

Tools

MS Project

Regulatory documentation tools

Job description

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, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

The Associate Director, 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, automation, and infrastructure, 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

Qualifications

• Bachelors degree in a business or a technical discipline.
• An advanced degree in either business or a technical field is desired. Relevant experience of 5 to 8 years with BS/BA and 3-5 years with Masters degree in addition to meeting the experience requirements
• 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

AI & Digital Fluency

Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

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.

Location and Compensation

Primary Location: Palo Alto, CA

Primary Location Base Pay Range: $199,400 - $274,200

Other US Location(s) Base Pay Range: $169,490 - $233,070

If the role is performed in Colorado, the pay range for this job is: $179,460 - $246,780

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 [e-mail]

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 our Privacy Notice for Job Applicants.

Company Culture

Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area.