Role Summary
We are seeking a seasoned, strategic Director of Clinical Operations to lead global clinical trial execution with a focus on Phase III programs. This role combines enterprise-level thinking with operational excellence, providing leadership across multiple studies or a full development program. The Director will drive global study delivery, ensure cross-functional alignment, oversee CRO and vendor partnerships, and elevate operational performance to support successful regulatory outcomes.
Core Responsibilities
Program & Study Leadership
- Provide strategic leadership for global Phase II–III clinical programs, with direct oversight of Phase III trial execution from protocol development through CSR and regulatory submission support
- Lead global enrollment strategy, forecasting, feasibility, and country/site optimization to ensure timely delivery
- Serve as a key member of cross-functional program teams, influencing clinical development strategy and lifecycle planning
- Partner with Clinical Science to support KOL engagement, advisory boards, and external collaborations
Global CRO, Vendor & Site Oversight
- Provide executive oversight of global CROs, functional service providers, and critical vendors
- Lead vendor selection, governance structures, and contract/budget negotiations for large-scale global trials
- Establish and monitor KPIs, quality metrics, and escalation pathways to ensure performance and accountability across regions
- Ensure high-performing site networks and strong site relationships globally
Financial & Resource Leadership
- Oversee and optimize multi-million-dollar global clinical program budgets
- Drive accurate forecasting, resource planning, and financial governance across programs
- Partner with Finance to ensure alignment with corporate goals and timelines
Quality, Compliance & Inspection Readiness
- Ensure full compliance with ICH-GCP, FDA, EMA, and global regulatory requirements
- Champion data integrity, audit readiness, and inspection preparedness at the program level
- Partner with QA to lead global inspection readiness strategies and manage regulatory interactions
Operational Excellence & Innovation
- Drive implementation of scalable processes, SOPs, and best practices across clinical operations
- Champion adoption of clinical technologies (eTMF, CTMS, RBM) and data-driven approaches
- Evaluate and implement innovative solutions (e.g., AI/ML, advanced analytics, decentralized trial components) to improve trial efficiency
Cross-Functional & Executive Collaboration
- Collaborate closely with Clinical Development, Regulatory Affairs, Data Science, Biometrics, CMC, and Supply Chain
- Provide operational insights to inform program-level decision-making and portfolio strategy
- Present program updates, risks, and mitigation strategies to senior leadership
Leadership & Team Development
- Build, lead, and mentor high-performing Clinical Operations teams
- Foster a culture of accountability, collaboration, and continuous improvement
- Develop talent pipelines and provide coaching to Associate Directors and Clinical Trial Leads