Associate Director, Portfolio Programs for IVD & NGS

Guardant Health, Inc.; Palo Alto (CA); Hybrid; USD 169,000 - 274,000; Full time

Job summary

Guardant Health, Inc. in Palo Alto seeks an Associate Director, Program Manager for new product development to lead a cross-functional core team.

You will drive end-to-end development of RUO, LDT, and IVD products, including NGS assays, automation, and infrastructure, ensuring quality systems and regulatory compliance across the project lifecycle. The role partners with marketing, regulatory, quality, medical affairs, and external partners to meet milestones, manage risks, and prepare for

Qualifications

• BS/BA in business or technical field; advanced degree preferred.
• PMP or similar certification highly desired.
• Experience in FDA-regulated environments is required.
• Experience leading cross-functional teams on medical device/IVD programs.

Responsibilities

• Lead cross-functional product development core team to deliver milestones.
• Coordinate with R&D, operations, quality, regulatory, and marketing.
• Lead joint projects with external partners to align with contractual milestones.
• Communicate program updates to senior leadership and stakeholders.
• Prepare for phase-gate reviews and manage resource planning.

Skills

Cross-functional leadership

Regulatory compliance

Project management tools

Agile & Waterfall

Leadership

N/A

Education

Bachelor's degree in business or technical field

Advanced degree desired

PMP or similar certification

Tools

N/A

Job description

Guardant Health, Inc. in Palo Alto seeks an Associate Director, Program Manager for new product development to lead a cross-functional core team.

You will drive end-to-end development of RUO, LDT, and IVD products, including NGS assays, automation, and infrastructure, ensuring quality systems and regulatory compliance across the project lifecycle. The role partners with marketing, regulatory, quality, medical affairs, and external partners to meet milestones, manage risks, and prepare for