Director Ivd Jobs (NOW HIRING)

Location: 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.
Associate Director, Strategic Program Management
We are seeking an experienced Associate Director of Project Management to join our PMO and lead high-complexity programs across our In Vitro Diagnostics (IVD) portfolio. This individual will simultaneously manage multiple large-scale projects and serve as a primary point of contact for pharma and biotech partners. The ideal candidate brings deep IVD domain expertise, a strong regulatory background including PMA submissions, and the leadership presence to drive cross-functional alignment independently and at pace.
This role requires someone who commands their programs, knowing every critical milestone, dependency, and risk from memory, proactively surfacing issues before they escalate, and leading stakeholder discussions to clear decisions without requiring manager intervention.
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
• Develop and maintain integrated master project schedules, risk registers, resource plans, and executive dashboards across the portfolio
• 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
• Independently manage stakeholder alignment discussions to closure, including resolving disagreement and ensuring clear decisions and next steps without requiring manager intervention
• 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
Required:

• 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
• Track record of proactive upward communication in fast-moving, high-stakes regulatory programs
• 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

Education

• Bachelor's degree in Life Sciences, Engineering, or a related field required
• Master's degree (MBA, MPH, MS) preferred

Compensation & Total Rewards
This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera's robust Total Rewards program, including:

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range
$166,700-$210,000 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing 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.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page