About Foresight DiagnosticsForesight 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.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.Why this role existsThe 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.Success 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’ll doDrive 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 requirementsSupport 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 deliverablesCoordinate regulatory submission readiness, including support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filingsLead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverablesTranslate product strategy into actionable program roadmaps, including timelines, milestones, and interdependencies, ensuring alignment with organizational priorities and securing stakeholder buy-inExtract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverablesPartner with Alliance Management to manage external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizationsAdhere 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-makingIdentify, track and manage program risks and dependencies, proactively identifying mitigation strategies and driving issue resolutionDrive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely executionSupport continuous improvement of product development processes, tools, and cross-functional ways of workingCultivate, build and maintain positive and collaborative relationships with cross-functional teamsWhat you’ll bring3-5+ years of experience in program management, or equivalent combination of project management and relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciencesExperience 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) preferredExposure to clinical trial operations and execution (preferred)Experience working with external partners, such as biopharma or CDx collaborations (preferred)PMP or equivalent certification preferredAbility to influence senior stakeholders and drive alignment in matrixed organizationsStrong organizational and program management skills, with the ability to manage multiple concurrent initiativesAnalytical mindset with strong attention to detail and ability to identify risks and dependenciesExcellent executive communication skills, with the ability to tailor messaging across technical and non-technical audiencesProficiency 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-makingThis position may be required to work across time zones as needed to support project schedulesCompensation, benefits & equal opportunityThis role offers a competitive annual base compensation of $120,000 - $140,000 commensurate with experience, and a comprehensive benefits package including:Medical, dental, and visionFlexible PTO and paid holidaysParental leave401(k) with company matchWe promote the professional development of our teams and encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer.
