Associate Director, Portfolio Program Management

About the Role

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. The Associate Director, Program Manager for new product development is a key leadership role responsible for leading 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 NGS assays, automation, and infrastructure, ensuring delivery of the product through launch while maintaining compliance with Guardant Health’s quality system deliverables and regulatory requirements. Experience with IVD or medical device product development is critical for success in this role.

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 align with 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, functional management, and 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, including root cause analysis and corrective action.
• Guide the team through phase gate reviews and other go/no-go decisions required by executive leadership.
• Oversee program planning, monitoring, and reporting.
• Ensure effective communications with core teams using a variety of tools and channels.
• Define program resource needs, negotiate resourcing plans, and track resource usage over the course of the program.
• Manage leadership stakeholders and present at executive management forums.
• Perform other related duties and assignments as required.

Requirements

• Bachelor’s degree in a business or technical discipline; an advanced degree in business or a technical field is desired.
• Relevant experience of 5 to 8 years with a BS/BA or 3 to 5 years with a Master’s degree, in addition to meeting other 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.
• 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.
• Ability to collect information from multiple sources, resolve conflicting requirements, and drive an organization toward 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. The 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 with 3 days a week onsite.

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 efficiency, effectiveness, and quality of work.

Schedule

All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays.

Pay

The annualized base salary ranges for this role are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need.

• Primary Location (Palo Alto, CA): $199,400 - $274,200
• Other U.S. Locations: $169,490 - $233,070
• Colorado: $179,460 - $246,780