Director, Clinical Operations

Education

• Bachelor’s or Master’s degree in life sciences or related scientific discipline required.

Preferred Qualificationsnice to have

• Experience supporting regulatory inspections and Phase 3 readiness activities is preferred.

Clinical Operations Strategy & Leadership

• Define and implement the clinical operations strategy in alignment with Zura Bio’s corporate and development objectives.

• Contribute to Clinical Development Plans and translate clinical strategy into integrated operational plans, timelines, and roadmaps aligned with key development milestones.

• Work cross-functionally to ensure alignment of activities across functions and clarify interdependencies.

• Serve as the senior Clinical Operations representative on cross functional workstreams and in senior leadership forums.

• Ensure operational considerations are embedded early in clinical development plans and protocols.

• Partner with senior clinical, regulatory, and functional leadership to support portfolio prioritization, investment trade-off decisions, and execution strategy.

• Where appropriate, recruit, hire, and line manage Clinical Operations professionals to ensure effective execution of clinical project plans and corporate objectives.

• As the company grows, contribute to the development of a best-in-class Clinical Operations function, including selection and implementation of optimized systems and processes.

• Evaluate and, where appropriate, pilot AI-enabled and automation tools (e.g., for feasibility, site selection, enrollment forecasting, and document drafting) to improve speed, quality, and efficiency, with appropriate governance and validation.

Trial Execution & Delivery

• Provide leadership and oversight for the planning, start-up, conduct, and closeout of global clinical trials.

• Ensure robust, integrated study plans, timelines, and budgets are in place to support high-quality execution and portfolio transparency.

• Review and approve feasibility assessments and provide leadership and decision-making for CRO selection and contracting activities.

• Provide oversight of CRO and vendor performance to ensure delivery against scope, timelines, quality, and cost.

• Identify and escalate portfolio and study-level risks, ensuring appropriate mitigation, contingency planning, and senior leadership visibility.

• Ensure high-quality, timely delivery of clinical study reports and operational contributions to regulatory submissions and other key corporate milestones.

• Track key performance indicators (KPIs) for study milestones, enrollment, cost, and quality, and communicate program status, risks, and issues to senior management to enable timely decisions.

• Use operational analytics and dashboards (e.g., enrollment, site performance, and cost forecasting) to anticipate risks and support proactive, data-driven decision-making.

• Work closely with Clinical Supply and CMC colleagues to ensure investigational product is available and managed appropriately for clinical studies.

• Oversee development and review of key study documents and plans (e.g., protocols, informed consent forms, monitoring and data management plans) with CROs and cross-functional partners.

CRO, Vendor & Quality Oversight

• Establish and maintain fit-for-purpose sponsor oversight and governance models appropriate for a lean biotech structure.

• Partner with Quality to ensure organization-wide inspection readiness across Clinical Operations, including oversight of TMF, systems, documentation, and inspection response preparedness.

• Oversee implementation of riskbased quality management (RBQM) and centralized monitoring strategies.

• Apply risk-based approaches across study planning and oversight, including risk assessments, key risk indicators, and quality tolerance limits, to focus resources on critical-to-quality factors.

• Drive continuous improvement in CRO performance, operational processes, study delivery metrics, and overall organizational execution capability.

• Foster a culture of continuous process improvement by encouraging lessons-learned reviews, root cause analysis, and data-driven refinement of Clinical Operations processes, tools, and ways of working.

• Ensure appropriate escalation, governance, and decision-making frameworks are in place across outsourced and internally managed activities.

• Contribute to the development and maintenance of SOPs, work instructions, and training to ensure ongoing GCP and ICH compliance across internal teams and outsourced partners.

• Lead vendor qualification and due diligence activities, and drive vendor governance through objective performance metrics, regular business reviews, and issue escalation.

• Act as the primary point of contact with CROs and study vendors, facilitating contract reviews for sites, vendors, and CROs and monitoring adherence to scope of work.

• Oversee set-up and maintenance of the Trial Master File and associated filing structures.

• As necessary, participate in vendor, site, and CRO audits and accompanied site monitoring visits.

Patient Recruitment, Site & Investigator Management

• Provide strategic leadership for patient identification, recruitment, and retention.

• Champion innovative and data‑driven recruitment approaches consistent with Zura Bio’s size and stage.

• Provide strategic oversight of investigator selection, site qualification, and site engagement strategies to support efficient global delivery.

• Support development of strong, credible relationships with investigators, key opinion leaders, and external partners critical to study execution.

• Represent Clinical Operations and advocate for Zura Bio studies with external collaborators, including sites, key opinion leaders, and patient advocacy groups, and present at investigator and other meetings as required.

Budget & Resource Management

• Own Clinical Operations budgets at study and program level, with accountability for forecast accuracy, spend discipline, and efficient deployment of resources.

• Lead resource planning across internal teams, consultants, and vendors, ensuring alignment with portfolio priorities and business needs.

• Monitor spend versus forecast and drive financial discipline across studies, including proactive management of trade-offs, assumptions, and delivery risks.

• Develop and manage study-level budgets, forecasts, accruals, and CRO and vendor contracts, work orders, and change orders in partnership with Finance, ensuring scope changes are justified and tracked against budget.

• Contribute to annual budget planning and long-range operating plan inputs for assigned studies.

• Provide clear, credible operational input to Executive Leadership

Our current benefits offerings include

• Medical, Dental, and Vision Plans

• Life and Disability Insurance

• Health Savings Account (HSA) and Flexible Spending Account (FSA)

• Equity Compensation

• Performance‑Based Bonus Program

• 401(k) Plan with Company Match

• Paid Time Off and Company Holidays

• Paid Parental Leave