Job Description
POSITION SUMMARY:
The Program Manager will lead cross-functional programs supporting product development initiatives at the Boulder, CO site. Projects and programs may include development, validation, and regulatory submission of diagnostic products; support of biopharma companion diagnostic (CDx) partnerships; and product sustainment and lifecycle management efforts. This role is responsible for driving execution across product development cross functional teams, including R&D, software, manufacturing, laboratory operations, quality, regulatory, clinical development, commercial, alliance management, and external partners, to ensure timely, compliant delivery of key milestones and contractual commitments.
The Program Manager will partner with functional leaders and stakeholders to translate product strategy into executable plans, manage cross-functional dependencies, and maintain alignment across internal and external stakeholders. This role requires strong program management fundamentals, experience and comfort operating in regulated environments, and the ability to coordinate complex, multi-disciplinary efforts simultaneously. The Program Manager will drive, communicate, and engage all project partners to enable accountability, problem solving, and on-time/within-budget delivery for simultaneous projects and programs. Success in this role requires onsite engagement (up to 25% travel) to facilitate rapid decision-making, build alignment, and resolve issues in a highly collaborative, fast-paced setting. This position reports to the Associate Director of Program Management.
PRIMARY RESPONSIBILITIES:
Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management across assay, software, and systems development, ensuring alignment with regulatory and business requirements.
Support regulatory product development activities, ensuring alignment with regulated processes and quality systems, including design control processes (ISO 13485), software lifecycle standards (IEC 62304), change management, and quality system requirements (FDA, CAP/CLIA), including documentation and traceability of requirements and deliverables.
Coordinate regulatory submission readiness, including support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings.
Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverables.
Translate product strategy into actionable program roadmaps, including timelines, milestones, and interdependencies, ensuring alignment with organizational priorities and securing stakeholder buy-in.
Extract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverables.
Partner with Alliance Management to manage external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizations.
Adhere to formal governance processes to communicate program status, risks, and trade-offs; escalate issues as needed; and present data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making.
Identify, track and manage program risks and dependencies, proactively identifying mitigation strategies and driving issue resolution.
Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution.
Support continuous improvement of product development processes, tools, and cross-functional ways of working.
Cultivate, build and maintain positive and collaborative relationships with cross-functional teams.
QUALIFICATIONS:
3-5+ years of experience in program management, or equivalent combination of project management and relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciences.
Experience supporting product development in regulated environments (IVD, medical device, or similar).
KNOWLEDGE, SKILLS, AND ABILITIES:
Background in NGS diagnostics, including assay and software components (MRD experience preferred).
Strong familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304).
Experience supporting regulatory submissions (e.g., IDE, 510(k), PMA, or equivalent) preferred.
Exposure to clinical trial operations and execution (preferred).
Experience working with external partners, such as biopharma or CDx collaborations (preferred).
PMP or equivalent certification preferred.
Ability to influence senior stakeholders and drive alignment in matrixed organizations.
Strong organizational and program management skills, with the ability to manage multiple concurrent initiatives.
Analytical mindset with strong attention to detail and ability to identify risks and dependencies.
Excellent executive communication skills, with the ability to tailor messaging across technical and non-technical audiences.
Proficiency with program management and collaboration tools (e.g., Smartsheets, JIRA, Office Timeline, etc.).
Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making.
This position may be required to work across time zones as needed to support project schedules.
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
