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Director, Clinical Operations

1 month, 2 weeks ago
United States
Full-time
Executive
Program Manager
Project and Program Management
Machine Learning
Apply Now
Karius

Karius

Karius is a life sciences company revolutionizing infectious disease diagnostics with the Karius Test™, a non-invasive liquid biopsy detecting over 1000 pathogens from a single blood sample.

Pharmaceuticals
51-250
Founded 2014
$254M raised
View All Jobs 9

Description

  • Design and implement a scalable clinical operations model for multi-study, multi-site execution across current and future programs.
  • Establish standardized processes, tools, and playbooks for site start-up, monitoring, enrollment management, and study oversight.
  • Define and track KPIs and dashboards to monitor study health, including enrollment, data quality, protocol deviations, and site performance.
  • Build and continuously improve systems that support consistent, inspection-ready execution across all studies.
  • Define and oversee site management and monitoring strategy, including resource allocation, monitoring models, and site engagement approaches.
  • Lead and develop the site operations function, including CRAs, contractors, and other site-facing personnel.
  • Identify operational risks, perform root cause analysis, and implement corrective and preventive actions to mitigate issues.
  • Build and evolve the Clinical Operations team structure, including roles, responsibilities, and development pathways for CTMs, CRAs, and support staff.
  • Coach, mentor, and develop team members to grow into program leadership roles within a structured operating model.
  • Manage clinical trial budgets, resource allocation, and forecasting to ensure efficient execution within budget.
  • Collaborate cross-functionally with Clinical Development, Data/Stats, and external partners to ensure aligned study execution.
  • Oversee vendor and CRO performance to ensure accountability, quality, and delivery against study objectives.
  • Maintain program status visibility and communicate progress, changes, issues, and risk mitigation strategies to stakeholders.
  • Ensure adherence to ICH-GCP, applicable regulations, internal procedures, and quality standards.

Requirements

  • Bachelor’s degree in a scientific, clinical, or health-related field required; advanced degree preferred.
  • 10+ years of progressive clinical operations experience, preferably in diagnostics, biotech, medical device, or pharmaceutical organizations.
  • 6+ years of people leadership experience, including building, managing, and developing high-performing teams.
  • Experience building or scaling clinical operations infrastructure in a growing organization.
  • Experience establishing operational KPIs, dashboards, and performance management systems for clinical trials.
  • Proven experience leading multi-site clinical studies from start-up through closeout, including studies supporting regulatory submissions.
  • Diagnostic clinical trial experience required; infectious disease diagnostics experience preferred.
  • Strong project and program management experience managing multiple concurrent studies within timelines and budgets.
  • Experience managing clinical trial budgets, forecasting, resource planning, and external vendors including CROs, consultants, and clinical sites.
  • Working knowledge of EDC systems, with Medrio preferred, and CTMS and eTMF systems, with Veeva preferred.
  • In-depth understanding of human subjects research, ICH-GCP guidelines, and FDA and CMS regulations.
  • Strong knowledge of clinical trial execution, monitoring practices, data quality standards, and regulatory compliance requirements.
  • Excellent written and verbal communication skills for scientific, clinical, operational, and executive stakeholders.
  • Experience managing external partners with clear expectations, performance oversight, and accountability.

Benefits

  • Hybrid role in Redwood City, CA or remote within the USA.
  • Full-time position.
  • Travel required up to 10%.
  • Salary range of $191,074 to $286,612 per year.

Interested in this position?

Apply directly on the company website

Apply Now

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