Program Manager

Foresight Diagnostics Inc.

. 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 .

Posted 4/21/2026full-timeRemote • Colorado • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $140,000 per yearWebsite

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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)
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., Smartsheet, 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.

Benefits

Comp & perks

Medical, dental, and vision
Flexible PTO and paid holidays
Parental leave
401(k) with company match

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

program managementproject managementproduct developmentdesign controlssoftware lifecycle processesregulatory submissionsclinical trial operationsNGS diagnosticsrisk managementchange management

Soft Skills

influenceorganizational skillsanalytical mindsetattention to detailexecutive communicationproblem solvingconflict resolutioncollaborationstakeholder managementcross-functional alignment

Certifications

PMP