Legend Biotech US

Executive Director, Clinical Operations Capabilities and Standards

Somerset, New Jersey, United States · Director

Sponsorship not specifiedDetected 5 days ago

ForecastingPerformance ManagementClinical TrialsLeadershipCollaborationGxP

About the role

The Executive Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department.
Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Clinical Trial Monitoring Standards, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations
including managing and developing staff within each pillar.

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:
Partner closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
Ensures vendors deliver high-quality services across the portfolio in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
Establish and maintain robust vendor governance, performance management via objective met-rics, issue escalation, and continuous improvement.
Establish and maintain robust vendor governance, performance management via objective met-rics, issue escalation, and continuous improvement. • Serves as escalation point for critical vendor-related risks and issues.
Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
The Executive Director, Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for clinical operations capability building and strengthening.

15+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
Proven expertise in end-to-end clinical trial conduct, including early-phase through late-phase trials, with strong understanding of protocol development, feasibility, start-up, execution, and close-out.
Significant experience in establishing, scaling, or transforming centralized

Oversee development and ownership of monitoring-related SOPs and/or oversee adoption of consistent CRO SOPs for monitoring)
Vendor Alliance Management:
Site contracts and Payments
Sample and Imaging Management Operations
Key Relationships
Minimum degree requirements of a bachelor's degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
Clinical Trial Planning & Analytics / Feasibility
Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
Site Contracts and Investigator Payments
Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financ
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases.

ty for improving opera-tional control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.