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 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 existsForesight Diagnostic’s clinical portfolio is growing, spanning companion diagnostic studies, investigator-initiated studies, and internally sponsored programs. Each requires a dedicated operational owner who can manage the full study lifecycle from start-up through reporting, maintain quality and compliance at every step, and serve as the primary interface between Foresight and its biopharmaceutical and research institution partners.This role reports to the Director of Clinical Operations and sits at the center of our cross-functional clinical team, collaborating daily with the clinical laboratory, bioinformatics, regulatory, medical affairs, and operations functions.What you’ll doImplement and maintain primary accountability for clinical study protocols and operational plans aligned with corporate strategic objectives.Manage day-to-day study operations in compliance with GCP/ICH guidelines and applicable regulatory requirements.Coordinate study timelines across cross-functional teams to hit critical milestones; proactively identify and resolve issues before they become blockers; manage escalation when needed.Provide oversight and direction to study team members (CRAs, Project Coordination) on study deliverables and performance.Train partners, sites, and internal team members on study protocols, operational plans, and applicable guidelines and regulations.Co-develop and manage study materials through their full lifecycle (protocols, operational plans, and applicable guidelines and regulations).Oversee the eTMF to ensure ongoing compliance and inspection readiness.Lead assigned internal and partner meetings, develop agendas, curate and file minutes, and maintain detailed dashboards and progress trackers to keep stakeholders clearly informed.Support process improvement initiatives and serve as a subject matter expert and mentor within the clinical operations function.What you’ll bringRequired5+ years of clinical trial experience in the biopharmaceutical or diagnostic industry, or at an academic medical center.3+ years leading project operational teams through the full study lifecycle, start-up, conduct, data management, and report writing/review.Experience working at or with a CRO, lab vendor, or biopharmaceutical company.Solid working knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research, with current GCP training documentation.Working knowledge of the FDA submission process including IDE, PMA, and 510(k).International study experience and familiarity with GDPR implementation.Experience managing complex clinical data sets, including genomic data.A self-starting, ownership-oriented approach—you don’t wait to be told what needs attention.Exceptional organizational skills and the ability to manage multiple concurrent priorities without dropping the details.Outstanding verbal and written communication skills, including strong email responsiveness and a genuine customer-service orientation towards partners and sites.Proficiency in Microsoft Office suite.Bachelor’s degree or equivalent in a scientific field, or an equivalent combination of education, training, and experience.PreferredDirect experience in precision oncology, MRD detection, or liquid biopsy clinical programs.Familiarity with companion diagnostic development pathways and co-development partnerships with biopharmaceutical companies.Experience with eTMF platforms and clinical trial management systems (CTMS).Background supporting regulatory submissions from a clinical operations documentation standpoint.Why join usThe team takes both the science and the operational craft seriously. Clinical operations here means real ownership, and you’ll work alongside regulatory, bioinformatics, and lab colleagues who bring the same level of investment to their work.We offer flexible work arrangements, promote from within, and are at a stage where the right people have genuine influence over how the function grows.Compensation, benefits & equal opportunityThis role offers a competitive annual base compensation of $150,000 - $170,000 commensurate with experience, and a comprehensive benefits package including:Medical, dental, and visionFlexible PTO and paid holidaysParental leave401(k) with company matchForesight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Ready to make an impact in cancer diagnostics? Apply below.
