Director, Clinical Ops — Global Phase 3 Leader

Zura Bio Ltd.

Northern (KY)

On-site

USD 200,000 - 236,000

Full time

4 days ago
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Benefits offered by this job

Medical, Dental, Vision
Equity Compensation
Performance-Based Bonus
401(k) with company match
PTO & Holidays

Job summary

Zura Bio Ltd. seeks a Director of Clinical Operations to lead the operational delivery of global development programs, including Phase 3 trials for BLA/NDA submissions.

You will oversee outsourced trials, ensure quality, speed, and regulatory compliance, and balance strategy with execution in a lean organization. The role requires strong judgment, analytics, and leadership of cross-functional teams, with a focus on AI-enabled tools, risk-based approaches, and continuous improvement to support

Qualifications

  • 10+ years in clinical operations, global drug development leadership.
  • Proven leadership of global trials and distributed teams.
  • Strong understanding of GCP and regulatory sponsor oversight.
  • Experience managing CROs/vendors and contract governance.
  • Hands-on budget management for studies and programs.

Responsibilities

  • Lead planning, start-up, conduct, and closeout of global trials.
  • Oversee study plans, timelines, and budgets for portfolio transparency.
  • Manage CRO/vendor performance and escalation of issues.
  • Drive risk-based quality management and continuous process improvement.
  • Represent Clinical Operations with external collaborators and sites.

Skills

Leadership
Global trial leadership
CRO/vendor management
Regulatory & GCP knowledge
Analytics & decision-making
AI-enabled tools

Education

Bachelor’s or Master’s in life sciences

Tools

CTMS
EDC
eTMF
AI tools

Job description

Zura Bio Ltd. seeks a Director of Clinical Operations to lead the operational delivery of global development programs, including Phase 3 trials for BLA/NDA submissions.

You will oversee outsourced trials, ensure quality, speed, and regulatory compliance, and balance strategy with execution in a lean organization. The role requires strong judgment, analytics, and leadership of cross-functional teams, with a focus on AI-enabled tools, risk-based approaches, and continuous improvement to support

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