Senior Director, Clinical Data Management

Who We Are:

Zura is a clinical‑stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‑mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach.

Zura is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity.

At Zura, we operate as One Zura. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining Zura means contributing to patient‑focused clinical development in a hands‑on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.

What You'll Do:

Zura Bio is seeking an experienced Clinical Data Management leader to build, lead, and scale the Clinical Data Management (CDM) function across a growing clinical portfolio. This Senior Director will provide strategic and operational leadership for all clinical data management activities, ensuring the delivery of high‑quality, timely, inspection‑ready clinical data that supports sound decision‑making, regulatory submissions, and long‑term program success.

In the near term, this role will operate with a high degree of hands‑on involvement, providing direct oversight of study‑level data management execution, CRO governance, and clinical data systems. Longer term, the Senior Director will define and drive the clinical data strategy across programs, establish scalable processes and standards, build and develop an internal team, and serve as a key member of the Clinical Development leadership team responsible for data integrity, governance, and operational excellence.

Responsibilities:

• Build and lead the Clinical Data Management function for Zura Bio, serving as the primary CDM representative on study and program teams.
• Collaborate with external vendors and Contract Research Organizations (CROs) to outsource certain Data management activities as needed.
• Manage vendor relationships and ensure deliverables meet quality and timeline expectations.
• Provide end‑to‑end oversight of clinical data management activities from protocol development through database lock and regulatory submission.
• Perform detailed protocol reviews with focus on endpoints, data flow, data collection strategy, and downstream analysis needs.
• Lead or oversee CRF design, database specifications, edit checks, data management plans (DMPs), and data review strategies.
• Ensure clinical data are complete, accurate, timely, traceable, and inspection‑ready in compliance with GCP, ICH, FDA/EMA guidance, and internal SOPs.
• Provide strategic oversight and hands‑on governance of CROs and external vendors delivering data management services, including scope definition, timelines, quality metrics, and issue escalation.
• Lead data quality review processes, including query trend analysis, reconciliation strategies, and proactive risk‑based monitoring approaches.
• Partner with Biostatistics and Statistical Programming to ensure delivery of clean, well‑documented, analysis‑ready datasets.
• Support interim analyses, safety reviews, and key data readouts through effective data review and collaboration.
• Establish, maintain, and continuously improve clinical data management processes, standards, SOPs, and work instructions to support scalability and audit readiness.
• Evaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, eCOA, RTSM) to enhance data quality, traceability, and operational efficiency.
• Define data standards, governance models, and quality frameworks that position clinical data as a strategic asset across programs.
• Contribute to data management budgets, vendor selection, and resource forecasting.
• Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Safety, Regulatory Affairs, Medical Affairs, and QA to enable integrated study execution.
• Provide clinical data management expertise in support of regulatory submissions (e.g., INDs, CSRs, NDA/BLA/MAA) and health authority interactions.
• Represent Clinical Data Management in inspections and audits, ensuring readiness and direct participation in responses to findings.
• Champion a culture of data integrity, quality, and continuous improvement across the organization.

Required Qualifications:

• 12\+ years of clinical data management experience in biotech, pharma, or CRO environments, with 5\+ years in functional leadership or people management roles.
• Demonstrated experience leading end‑to‑end clinical data management for Phase 1–3 clinical trials, including global, multicenter studies.
• Proven track record of CRO/vendor oversight and delivery of high‑quality, regulatory‑compliant clinical data.
• Deep knowledge of clinical data management processes, EDC systems, CDISC standards, and data integrity principles.
• Strong understanding of GCP, ICH, and global regulatory expectations related to clinical data.
• Experience supporting regulatory submissions and inspection readiness activities.
• Ability to operate effectively in a hands‑on, matrixed, fast‑paced clinical‑stage biotech environment.
• Strong communication, leadership, and cross‑functional collaboration skills.

Preferred Qualifications:

• Therapeutic area experience in autoimmune or inflammatory diseases preferred.

Education:

• Advanced degree in Life Sciences, Clinical Research, Data Science, or a related discipline; a BS with significant relevant experience will be considered.

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