Director, Clinical Operations

Zura Bio Limited (Nasdaq: ZURA); United States; On-site; USD 200,000 - 236,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life & Disability Insurance

HSA/FSA

Equity Compensation

Performance‑Based Bonus

401(k) Plan with Company Match

PTO & Holidays

Parental Leave

Job summary

Zura Bio Limited is seeking a Director of Clinical Operations to lead global clinical development programs, including Phase 3 studies for BLA/NDA readiness. You will oversee outsourced trials, drive operational excellence, and partner with cross-functional teams to ensure quality, speed, and regulatory compliance.

The role requires extensive experience in global trials, strong leadership, and a track record of successful regulatory submissions; candidates should balance strategic planning with

Qualifications

• 10+ years of progressive clinical operations experience, including leadership in global drug development.
• Proven track record leading global clinical trials and cross-functional teams.
• Strong understanding of global regulatory environment (GCP, regulations) and sponsor oversight.

Responsibilities

• Define and implement the clinical operations strategy aligned with corporate objectives.
• Translate clinical strategy into integrated operational plans, timelines, and roadmaps.
• Oversee CRO/vendor performance and ensure delivery against scope, budget, and quality.
• Lead patient recruitment strategies and site/c investigator management.
• Own study budgets, forecasts, accruals, and contract management with Finance.

Skills

Global clinical ops leadership

Phase 3 experience

GCP/regulatory knowledge

Budgeting & forecasting

Vendor/CRO management

AI-enabled tools

Team management

Inspection readiness

Education

Bachelor’s or Master’s in life sciences

Tools

CTMS

EDC

eTMF

Job description

What You’ll Do

The Director, Clinical Operations is a senior leader accountable for the operational delivery of Zura Bio’s global clinical development programs, including Phase 3 studies supporting BLA/NDA submissions. This role serves as the key point of accountability for clinical trial delivery, ensuring studies are executed to the highest standards of quality, speed, and regulatory compliance to support successful registrations and future commercialization. The Director, Clinical Operations provides functional leadership in a fast-paced biotech environment, helping shape the Clinical Operations operating model and working closely with internal cross functional teams and external partners (CROs, vendors, investigative sites). Director, clin ops combine strong oversight of an outsourced trial model with inspection readiness, disciplined budget and financial management, and a commitment to continuous improvement through analytics, risk-based approaches, and emerging technologies, including AI-enabled tools. The role requires strong judgment, operational rigor, and the ability to balance strategy with execution in a resource-conscious organization.

Responsibilities

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 elevate 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

Required Qualifications

• 10+ years of progressive clinical operations experience, including meaningful leadership responsibility in global drug development.
• Proven track record of successful leadership and management of global clinical trials and internationally distributed teams.
• Strong understanding of the global regulatory environment, including GCP, clinical trial regulations, and sponsor oversight expectations.
• Excellent communication, negotiation, and problem‑solving skills
• Proven ability to lead CROs and vendors in outsourced trial models, including governance, performance management, and strategic oversight.
• Direct experience leading the global conduct of Phase 3 studies supporting BLA/NDA submissions, from study start‑up through database lock and clinical study report.
• Demonstrated regulatory inspection experience, including preparation for, hosting, and response to health authority inspections (e.g., FDA, EMA) and sponsor/CRO audits.
• Strong oversight experience in a predominantly outsourced model, including CRO and vendor governance, performance and quality management, issue escalation, and accountability for delivery.
• Hands‑on experience managing clinical trial budgets, forecasts, and CRO and vendor contracts, including change order negotiation.
• Experience in a small to mid‑size biotech or similarly lean environment, with comfort operating in a hands‑on, resource‑conscious setting.
• Working knowledge of clinical systems and technologies (e.g., CTMS, EDC, eTMF) and their oversight in CRO‑managed studies.
• Experience applying analytics, risk‑based quality management, and emerging technologies (including AI‑enabled tools) to improve trial planning, oversight, and execution.
• Experience in direct line management of clinical operations staff.
• Demonstrated ability to build a culture of continuous improvement, including implementing process enhancements and applying lessons learned across studies.
• Excellent interpersonal skills, strategic thinking, and emotional intelligence, with the ability to build strong relationships with key stakeholders across disciplines.
• Demonstrated ability to prioritize multiple tasks and stakeholders in a dynamic, fast‑paced environment with changing priorities and tight deadlines.
• Experience representing a company in external interactions and engagements, with a high level of integrity, ethics, and discretion.
• Collaborative team player with a solid record of working across functional areas, committed to a supportive and empowering work culture.
• Willingness to travel as needed, including periodic travel to Zura offices in London and to CRO, vendor, and investigator sites (approximately 25–30%).

Preferred Qualifications

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

Education

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

Expected Salary Range

$200,000 - $236,000 USD

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