Associate Director, New Product Introduction (NPI)/Program Management
About The Position
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, New Product Introduction (NPI)/Program Management is a senior leadership role responsible for strategic oversight and execution of complex, cross-functional product development programs spanning RUO, LDT, and IVD offerings. This role drives end-to-end portfolio delivery, ensures regulatory and quality compliance, and serves as a key partner to executive leadership in advancing Guardant Health’s product and business strategy. The Associate Director leads multiple high-impact programs and/or a critical product platform, guiding cross-functional teams through development, launch, and lifecycle management. This role requires deep experience in FDA-regulated medical device or IVD development, strong executive presence, and the ability to operate at both strategic and operational levels. In addition to program ownership, the Associate Director provides functional leadership, mentors program managers, influences organizational best practices, and represents Program Management in enterprise decision-making forums.
Requirements
- Bachelor’s degree in a technical or business discipline required; advanced degree strongly preferred
- 10+ years of progressive program or project management experience in regulated environments
- 7+ years leading complex, cross-functional product development programs in IVD, medical device, or diagnostics
- Demonstrated success launching FDA-regulated products from concept through commercialization
- Proven experience managing complex systems with multiple interdependent sub-projects
- PMP or equivalent certification strongly preferred
- Expert knowledge of program management methodologies, tools, and financial/resource management
- Experience with both Agile and Waterfall execution models
- Strong executive communication, influence, and stakeholder management skills
Responsibilities
- Strategic & Portfolio Leadership
- Provide strategic leadership for one or more complex NPI programs or a portfolio of programs aligned with corporate objectives
- Partner with senior leadership to translate business strategy into executable program plans, timelines, and resource strategies
- Drive portfolio-level prioritization, trade-off decisions, and risk mitigation in alignment with enterprise goals
- Program & Execution Leadership
- Lead cross-functional core teams (R&D, Operations, Quality, Regulatory, Medical Affairs, Marketing, Bioinformatics, Reagent Development) to deliver products through successful launch
- Oversee development and maintenance of program plans, budgets, schedules, and risk registers
- Ensure timely completion and integrity of Design History File (DHF) and other regulated deliverables
- Lead teams through complex issue resolution, including root cause analysis, corrective actions, and escalation management
- Prepare and lead executive phase-gate reviews, investment decisions, and go/no-go recommendations
- Contribute to the development of program management standards, tools, and best practices
- External & Executive Engagement
- Serve as the primary program interface with external partners, ensuring alignment to contractual milestones and deliverables
- Communicate program status, risks, and strategic implications to executive leadership with clarity and confidence
- Represent Program Management at executive management forums and cross-enterprise initiatives
- Governance, Compliance & Continuous Improvement
- Ensure adherence to Guardant Health quality systems, FDA regulations, and internal governance processes
- Champion continuous improvement in program execution, communication, and cross-functional collaboration
- Influence adoption of Agile, Waterfall, or hybrid methodologies appropriate to program needs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
