Program Manager
Natera
- Location
- US Remote
- Work model
- Remote
- Level
- Senior
- Salary
- $103.8k – $129.7k/yr
- H-1B history
- 12 approvals (FY2023)
- Posted
- 3h ago
Skills
About this role
Location: Remote or On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)
Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.
We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.
Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.
About the Role
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.
What you will do
• 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,