Lead cross-functional programs supporting product development initiatives at the Boulder, CO site.
Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management across assay, software, and systems development.
Support regulatory product development activities, ensuring alignment with regulated processes and quality systems.
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.
Partner with Alliance Management to manage external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizations.
Identify, track and manage program risks and dependencies.
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
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).