The Program Manager will lead cross-functional programs supporting product development initiatives at the Boulder, CO site, driving execution across product development cross-functional teams, and managing cross-functional dependencies. The role requires strong program management fundamentals, experience and comfort operating in regulated environments, and the ability to coordinate complex, multi-disciplinary efforts simultaneously.
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).
- 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.
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- 401k benefits.
- Commuter benefits.
- Pregnancy and baby bonding leave.
- Generous Paid Time Off.