Director Clinical Operations at Enigma Search in South San Francisco, California, United States

Job description

• 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.

Responsibilities

• Core Responsibilities
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Requirements

• Seasoned, strategic Director of Clinical Operations
• Lead global clinical trial execution with a focus on Phase III programs
• 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
• 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
• Oversee and optimize multi-million-dollar global clinical program budgets
• Ensure full compliance with ICH-GCP, FDA, EMA, and global regulatory requirements
• Champion data integrity, audit readiness, and inspection preparedness at the program level
• 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)
• Collaborate closely with Clinical Development, Regulatory Affairs, Data Science, Biometrics, CMC, and Supply Chain
• Build, lead, and mentor high-performing Clinical Operations teams
• Develop talent pipelines and provide coaching to Associate Directors and Clinical Trial Leads

Skills

Required

• Strategic leadership
• Operational excellence
• Global clinical trial execution
• CRO and vendor management
• Budget management
• Data integrity and audit readiness
• Process improvement
• Cross-functional collaboration
• Team leadership and mentoring