Sr. Director, Clinical Operations Capabilities and Standards

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will provide strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department.

Key Responsibilities

• Establish, oversee, and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

• Act as the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Relationships

• Closely works with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.

• 12+ 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:

  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations

• 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.

• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.

• Experience acting as a functional or enterprise-level clinical operations subject-matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.

• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.

• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.

• Demonstrated success leading, developing, and retaining high-performing teams, including functional leaders.

• Willingness to travel as required (approximately 10%).

• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH-GCP, FDA, and global health authorities).

• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.

• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.

• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.

• Ability to translate portfolio-level strategy into executable clinical operations capabilities, standards, and guidance.

• Proven strategic and critical thinking skills, with a data-driven mindset and ability to anticipate operational risks and mitigation strategies.

• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.

• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross-functional teams.

• High proficiency with clinical operations-relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision-making.