Program Manager

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Oversee the complete execution of product development initiatives, which includes planning, scheduling, resource coordination, and risk management across assay, software, and systems development, ensuring compliance with regulatory and business standards.

• Assist in regulatory product development efforts, making sure they align with regulated processes and quality systems, such as design control processes (ISO 13485), software lifecycle standards (IEC 62304), change management, and quality system requirements (FDA, CAP/CLIA), including the documentation and traceability of requirements and deliverables.

• Prepare for regulatory submissions, providing support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings.

• Facilitate cross-functional collaboration among R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverables are established.

• Convert product strategy into actionable program roadmaps that include timelines, milestones, and interdependencies, ensuring alignment with organizational goals while securing stakeholder support.

• Gather and refine user needs and requirements from stakeholders, guiding teams to concentrate on the most impactful deliverables.

• Collaborate with Alliance Management to oversee external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizations.

• Follow formal governance processes to relay program status, risks, and trade-offs; escalate issues when necessary; and present data-driven recommendations and business proposals to senior leadership for timely and informed decision-making.

• Identify, monitor, and manage program risks and dependencies, proactively developing mitigation strategies and driving issue resolution.

• Foster cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution.

• Contribute to the continuous improvement of product development processes, tools, and collaborative practices.

• Build and maintain positive and collaborative relationships with cross-functional teams.

⛳️ Requirements

• 3-5+ years of experience in program management or a comparable combination of project management and relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciences.

• Experience in supporting product development within regulated environments (IVD, medical device, or similar).

• Background in NGS diagnostics, including both assay and software components (MRD experience preferred).

• Strong understanding of design controls (ISO 13485) and software lifecycle processes (IEC 62304).

• Preferred experience in supporting regulatory submissions (e.g., IDE, 510(k), PMA, or equivalent).

• Familiarity with clinical trial operations and execution is preferred.

• Experience collaborating with external partners, such as biopharma or CDx collaborations, is preferred.

• PMP or equivalent certification is preferred.

• Capability to influence senior stakeholders and drive consensus in matrixed organizations.

• Strong organizational and program management capabilities, with the ability to handle multiple concurrent initiatives.

• Analytical mindset accompanied by strong attention to detail and the ability to recognize risks and dependencies.

• Exceptional executive communication skills, with the ability to customize messaging for both technical and non-technical audiences.

• Proficient in program management and collaboration tools (e.g., Smartsheet, Jira, Office Timeline, etc.).

• Possess situational awareness, alongside facilitation, problem-solving, and conflict resolution skills to promote cross-functional decision-making.

• This role may require working across time zones as necessary to meet project schedules.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Flexible PTO and paid holidays.

• Parental leave.

• 401(k) plan with company matching.