Sr. Director, Clinical Operations Capabilities and Standards

Responsibilities

• Provide strategic leadership and oversight for foundational and centralized trial operations support to ensure cost-effective scalability.
• Establish and grow capability pillars including Clinical Trial Planning and Analytics, Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management.
• Serve as the company subject-matter expert for clinical operations standards applied across the portfolio.
• Oversee end-to-end clinical trial feasibility, protocol optimization, and enrollment forecasting.
• Drive strategic ownership and governance of core clinical systems such as CTMS and eTMF.
• Manage external clinical operations vendors and CRO partners, ensuring compliance with GxP and contractual expectations.
• Develop and oversee scalable operating models for site contracting and investigator payment operations.
• Lead the development and authoring of clinical operations SOPs and guidance documents.

Requirements

• Bachelor’s degree in a scientific or healthcare discipline (Advanced degree preferred).
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations.
• Demonstrated leadership in global clinical development programs.
• Significant experience scaling centralized capabilities like Clinical Trial Planning, Operational Technologies, or Vendor Alliance Management.
• Proven expertise in end-to-end clinical trial conduct from early-phase through late-phase.
• Strong background in CRO and vendor oversight, including governance and performance metrics.
• Deep knowledge of ICH-GCP, FDA, and global regulatory expectations.
• Ability to lead and develop high-performing functional teams.
• Willingness to travel approximately 10%.

Preferred Qualifications

• Experience supporting regulatory authority interactions such as FDA inspections.
• Expertise in clinical operations technology enablement and data quality oversight.

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across diverse technology platforms, including autologous and allogenic CAR-T, TCR-T, and NK cell-based immunotherapy.