Director, Clinical Operations

The Director, Clinical Operations at Karius is responsible for building and leading a scalable, high-performance clinical operations function to support the execution of diagnostic clinical programs, including multi-site clinical trials, with a focus on quality, speed, and efficiency.

Location: Remote (USA) or Redwood City, CA (Hybrid)

Salary: $191,074 – $286,612

Responsibilities

• Design and implement a scalable clinical operations model for multi-study, multi-site execution.
• Establish standardized processes, tools, and playbooks for study start-up, monitoring, enrollment, and oversight.
• Define and monitor KPIs and dashboards for study health.
• Build and improve systems for consistent, inspection-ready execution.
• Define and oversee site management and monitoring strategies.
• Lead and develop the site operations function, including oversight of CRAs and site personnel.
• Ensure proactive risk management and operational oversight.
• Build and evolve the Clinical Operations team structure, roles, and responsibilities.
• Coach and develop team members for growth into leadership roles.
• Manage clinical trial budgets, resources, and forecasting.
• Collaborate with cross-functional teams and external partners.
• Oversee vendor and CRO performance.
• Maintain oversight of program status, issues, risks, and dependencies.

Requirements

• Bachelor’s degree in a scientific, clinical, or health-related field; advanced degree preferred.
• 10+ years of clinical operations experience, preferably in diagnostics, biotech, or pharma.
• 6+ years of people leadership experience.
• Experience building or scaling clinical operations infrastructure.
• Experience establishing operational KPIs and dashboards.
• Proven ability to create structure and drive accountability.
• Experience leading multi-site clinical studies, including regulatory support.
• Experience in diagnostic clinical trials, preferably infectious disease diagnostics.
• Strong project and program management skills.
• Experience managing budgets, forecasting, and external vendors.
• Knowledge of electronic data capture systems, CTMS, eTMF systems.
• Understanding of human subjects research, ICH-GCP, FDA, CMS regulations.

Additional Information

• Travel required up to 10%.
• Position based in Redwood City, CA (Hybrid) or Remote (USA).