Associate Director, Strategic Program Management
About the role
This is a hybrid role based out of our San Carlos, CA headquarters. We are looking for someone who lives within a reasonable commute and is comfortable coming into the office a couple of times per month.
Key Responsibilities
- Lead and manage multiple concurrent IVD development programs from initiation through commercialization, ensuring on-time, on-budget, and on-scope delivery
- Maintain real-time command of all program milestones, dependencies, and critical dates across the portfolio, able to communicate status with confidence in any stakeholder conversation without referencing documents
- Own the change control log and regulatory impact assessments for IVD programs independently, including verification of inputs from Lab Director, LabOps, reagent, software, and partner teams
- Serve as the primary PMO liaison for pharma and biotech partner relationships, managing joint governance, reporting cadences, and escalation paths
- Lead cross-functional meetings to clear decisions and documented action items; does not leave discussions open or defer without direction
- Build and maintain stakeholder confidence through structured, accurate, and proactive communication at all levels
- Drive PMA submission readiness, coordinating cross-functional workstreams across R&D, Regulatory Affairs, Quality, Clinical, and Manufacturing
- Standardize and continuously improve PMO frameworks, tools, and templates aligned with IVD regulatory requirements (21 CFR Part 820, ISO 13485)
- Proactively surface risks, changes, and issues to leadership before they escalate; ensure manager has full visibility at all times
- Provide structured, substantive updates to leadership covering priorities, progress, risks, and support needed, without being prompted
- Facilitate project governance forums, steering committees, and partner-facing reviews with clear, structured communication
- Mentor and coach junior PMs within the PMO function
- Partner with Finance to manage project budgets, forecasting, and resource utilization across the portfolio
Qualifications
- 12+ years of project management experience, with at least 3 years managing IVD or medical device programs
- Direct experience supporting or leading PMA (Premarket Approval) submissions with FDA
- Proven ability to manage multiple large, complex programs simultaneously in a matrixed organization
- Experience managing pharma or biotech partner relationships, including joint project governance
- Strong understanding of IVD development lifecycle, design controls, and 21 CFR Part 820 / ISO 13485 requirements
- Exceptional stakeholder communication skills, able to present to senior leadership and external partners with confidence
- Demonstrated ability to independently lead and close stakeholder alignment discussions without manager escalation
- Comfortable being "on the spot" with partners and senior leadership regarding program status, timelines, and risks
- Exceptional command of integrated project planning: dependencies, sequencing, critical path, and milestone ownership
- Proficiency with project management tools (MS Project, Smartsheet, or equivalent)
Preferred
- PMP, PgMP, or equivalent certification
- Experience with companion diagnostics (CDx) co-development programs
- Familiarity with EU IVDR and global IVD regulatory pathways
- Background in clinical or analytical laboratory settings
Compensation & Total Rewards
Compensation Range: $166,700—$210,000 USD
Our Opportunity
Natera™ is a global leader in cell-free DNA (cfDNA) sing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic sing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.