Director, Clinical Operations

About KariusKarius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.Position Summary The Director, Clinical Operations is responsible for building and leading a scalable, high-performance clinical operations function to support the execution of Karius’ diagnostic clinical programs. This role goes beyond study execution to establish the systems, processes, and operating model required to deliver multi-site clinical trials with consistency, quality, and speed. The Director will define and implement the clinical operations infrastructure, including site management strategy, monitoring frameworks, performance metrics, and team structure, ensuring the organization is positioned to scale efficiently.Reporting to the SVP, Clinical Affairs, this individual will lead a growing Clinical Operations team and serve as the operational backbone across programs, enabling strong program leadership, proactive risk management, and inspection readiness.Why Should You Join Us?Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.Reports to: SVP, Clinical AffairsLocation: Redwood City, CA (Hybrid) or Remote (USA)Primary ResponsibilitiesClinical Operations Strategy & InfrastructureDesign and implement a scalable clinical operations model to support multi-study, multi-site execution across OPTIMUM, AXIS, and future programs.Establish standardized processes, tools, and playbooks for site start-up, monitoring, enrollment management, and study oversight.Define and implement key performance indicators (KPIs) and dashboards to monitor study health (e.g., enrollment, data quality, protocol deviations, site performance).Build and continuously improve systems to ensure consistent, inspection-ready execution across all studies.Site Operations & Monitoring ExcellenceDefine and oversee the site management and monitoring strategy, ensuring appropriate resource allocation, monitoring models, and site engagement approaches.Lead and develop the site operations function, including oversight of CRAs, contractors, and site-facing personnel.Ensure consistent, high-quality monitoring practices and proactive issue identification and escalation across sites.Partner with the Sr. Manager, Site Operations (or equivalent) to drive day-to-day execution excellence.Operational Oversight & Risk ManagementEstablish clear oversight mechanisms to ensure visibility into study performance, including enrollment, data entry compliance, protocol deviations, and site activation timelines.Proactively identify operational risks and implement mitigation strategies, including root cause analysis and corrective/preventive actions (CAPA).Ensure strong governance and accountability across all levels of the clinical operations team.Team Design & DevelopmentBuild and evolve the Clinical Operations team structure to support scale, including defining roles, responsibilities, and development pathways across CTMs, CRAs, and support staff.Coach and develop junior team members (e.g., Clinical Trial Managers) to grow into program leadership roles within a structured and supportive framework.Ensure appropriate layering of responsibilities between program leadership and site execution.Ensure effective execution of clinical trials through a structured operating model that enables consistency across programs rather than reliance on individual contributors.Mentor and develop Clinical Operations team members, providing guidance, training, coaching, and support to foster professional growth, accountability, and excellence in performance.Build and strengthen a high-quality, scalable Clinical Operations team and infrastructure capable of supporting the organization’s clinical and regulatory objectives.Manage all clinical trial budgets