Senior Director, Clinical Ops Excellence/Performance & Delivery

Key Responsibilities

• Lead the development, implementation and continuous improvement of Clinical Operations processes, standards, tools and governance frameworks
• Establish scalable operational infrastructure to support growth across a multi-program clinical portfolio
• Drive consistency across study execution models, documentation standards and operational workflows
• Develop and maintain Clinical Operations, templates, trackers and best practices
• Provide input to Clinical Operations SOPs
• Identify operational gaps, inefficiencies and process improvement opportunities across the organization
• Develop and deliver high-quality presentations and executive-level materials for Board meetings, senior leadership, and internal and external stakeholders
• Partner with study teams and leadership to monitor study performance, timelines, risks and operational health
• Drive operational accountability through clear performance tracking and proactive issue escalation
• Support portfolio-level planning, resource forecasting and operational prioritization
• Establish governance models and operational review processes that improve execution visibility and decision-making
• Develop and oversee Clinical Operations KPIs, metrics dashboards and delivery reporting frameworks
• Develop and deliver high-quality presentations and executive-level materials for Board meetings, senior leadership, and internal and external stakeholders
• Partner with study teams to ensure vendor deliverables, timelines and quality expectations are consistently met
• Lead operational business reviews and performance discussions with key vendors
• Support vendor selection, onboarding and governance strategies across the clinical portfolio
• Help optimize external partnerships to improve operational quality, efficiency and scalability
• Cross-Functional Operational Leadership
• Partner closely with Clinical Development, Biometrics, Regulatory Affairs, Clinical Quality, Clinical Supply and Finance to support integrated study delivery
• Serve as an operational advisor to Clinical Operations leadership on delivery risks, resource planning and execution strategy
• Facilitate cross-functional alignment around timelines, priorities and operational expectations
• Support inspection readiness and quality-focused operational practices across programs
• Organizational Development & Team Leadership
• Mentor and develop Clinical Operations team members and operational leaders
• Foster a culture of accountability, collaboration, urgency and operational excellence
• Help shape organizational structure, roles and scalable operational support models as the company grows
• Contribute to strategic planning initiatives within Clinical Operations and broader Development organization

Required Education And Experience

• Bachelor’s degree required; advanced scientific, healthcare or business degree preferred
• 12+ years of biotech/pharmaceutical clinical operations experience, including leadership responsibility across
• Significant experience building or leading Clinical Operations Excellence, delivery management, operational strategy or portfolio oversight functions
• Deep understanding of Phase 1–3 clinical trial execution and operational delivery models
• Strong experience managing CROs and external vendors within lean biotech or fast-growth environments
• Demonstrated success driving operational improvements and organizational scalability