Executive Director, Data Management

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Full Time Management Berkeley, CA, US

6 days ago Requisition

Salary Range: $ To $ Annually

Ray Therapeutics mission is to restore vision to people with retinal degenerations. Ray Tx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

The Executive Director of Data Management is a senior clinical-development leader responsible for establishing and executing Ray Therapeutics’ global clinical data-management strategy across its portfolio. This individual will build and lead a scalable, inspection-ready data-management function that delivers high-quality, timely, and reliable clinical data to support decision-making, regulatory submissions, and the advancement of innovative optogenetic therapies for retinal degenerative diseases.

The Executive Director will provide strategic and operational leadership across study start-up, conduct, database lock, submission, and archival. The role will partner closely with Clinical Operations, Clinical Science, Biostatistics, Statistical Programming, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Quality, Information Technology, and external service providers to ensure that data-management processes, systems, standards, and deliverables meet program needs, applicable regulations, and industry best practices.

Formula for Success:
Combining strategic leadership, deep clinical data-management expertise, and hands-on execution to build a scalable function and deliver submission-ready clinical data; you will:

• Define and lead the clinical data-management vision, operating model, roadmap, and resourcing strategy across the portfolio
• Build, develop, and lead a high-performing internal team and fit-for-purpose network of contract resources and service providers
• Provide data-management leadership from protocol development and study start-up through database lock, regulatory submission, and archival
• Oversee development and maintenance of data-management plans, electronic case report forms, edit-check specifications, data-transfer agreements, reconciliation plans, coding conventions, and database lock plans
• Establish and govern clinical data standards, including CDISC-aligned practices, controlled terminology, metadata, and reusable libraries
• Ensure effective integration, reconciliation, and traceability of data from electronic data-capture systems, imaging platforms, central laboratories, safety databases, patient-reported outcomes, devices, and other external sources
• Drive risk-based data review and data-cleaning strategies that support timely identification and resolution of critical data issues
• Define and monitor quality, cycle-time, and vendor-performance metrics; proactively identify risks, root causes, and corrective actions
• Select, qualify, and oversee data-management vendors and technology platforms, including scope, budget, timelines, performance, and inspection readiness
• Partner with Biostatistics and Statistical Programming to ensure clean, complete, analysis-ready datasets and coordinated database locks
• Author and maintain data-management standard operating procedures, work instructions, templates, training, and quality-control processes
• Represent Data Management on cross-functional development teams, governance forums, regulatory interactions, audits, and inspections
• Contribute to regulatory submission planning and delivery, including data traceability, documentation, and responses to health-authority questions
• Develop functional budgets, resource forecasts, and long-range capability plans aligned with portfolio priorities
• Promote a culture of accountability, collaboration, continuous improvement, data integrity, and patient focus

• Bachelor’s degree in life sciences, computer science, information systems, biostatistics, or a related discipline required; advanced degree preferred
• Typically 12 or more years of progressive clinical data-management…