VP, Global Clinical Data Management & Strategy

Ray Therapeutics, Inc.; Berkeley (CA); Hybrid; USD 315,000 - 375,000; Full time

Job summary

Ray Therapeutics, Inc. seeks an Executive Director / Vice President of Data Management to establish and execute a global data-management strategy across its portfolio.

You will build a scalable, inspection-ready function delivering high-quality data for regulatory submissions and decision-making. Lead start-up through archival, partner with Clinical Operations, Biostatistics, Regulatory Affairs, and external vendors to ensure CDISC standards, data integrity, and timely delivery across multi-site

Qualifications

• Bachelor’s degree in life sciences, computer science, information systems, biostatistics, or a related discipline required; advanced degree preferred
• 12+ years of progressive clinical data-management experience with leadership responsibility
• Experience leading data management across global clinical programs from early development through pivotal studies and regulatory submissions
• Proven ability to build or scale a clinical data-management function, organization, systems, standards, and vendor model in a growing company
• Direct experience with electronic data-capture platforms, clinical data review tools, medical coding, external data integration, database validation, and database lock
• Strong knowledge of CDISC standards and regulatory expectations for clinical data, including FDA/ICH-GCP guidance
• Experience supporting regulatory submissions, health-authority interactions, audits, and inspections
• Demonstrated success selecting and managing CROs, FSOs, and technology vendors
• Understanding of clinical-trial design, data flows, safety/lab reconciliations, statistics, and cross-functional dependencies
• Experience in ophthalmology, retinal disease, gene therapy, AAV, optogenetics or related therapies desirable
• Strategic and analytical mindset to translate portfolio needs into scalable processes and systems
• Excellent leadership, communication, and presentation skills; able to work across functions
• Track record of attracting and retaining talent and leading through growth
• Ability to manage multiple priorities in a fast-paced biotech environment
• Ability to travel ~20%
• Ability to work in Berkeley office 3 days per week

Responsibilities

• Define and lead the clinical data-management vision, operating model, roadmap, and resourcing strategy across the portfolio
• Build and lead a high-performing internal team and a network of contract resources
• Provide data-management leadership from protocol development through database lock and submission
• Oversee development of data-management plans, eCRFs, edit-check specs, data-transfer agreements, reconciliation plans, coding conventions, and database lock plans
• Establish and govern data standards, CDISC-aligned practices, terminology, metadata, and reusable libraries
• Ensure integration and traceability of data from multiple sources including EDC, imaging, labs, and patient-reported outcomes
• Drive risk-based data review and data-cleaning strategies for timely issue resolution
• Define and monitor quality, cycle-time, and vendor performance metrics; manage risks and corrective actions
• Select and oversee data-management vendors and platforms, including scope, budget, timelines, and inspection readiness
• Collaborate with Biostatistics to ensure clean, complete, analysis-ready datasets
• Author and maintain SOPs, WIs, templates, training, and QC processes
• Represent Data Management on cross-functional teams, governance forums, and regulatory interactions
• Contribute to regulatory submission planning and responses to health-authority questions
• Develop budgets and long-range capability plans aligned with portfolio priorities
• Promote accountability, collaboration, data integrity, and patient focus
• Travel availability and flexibility to support roles in Berkeley

Skills

Leadership

Clinical data-management

Regulatory submissions

CDISC standards

Vendor management

Data-management strategy

Ophthalmology experience

Communication skills

Travel required

Education

Bachelor’s degree in life sciences, CS, IS, biostatistics or related

Advanced degree preferred

Tools

Electronic data-capture platforms

Data-management systems

Quality systems

Job description

Ray Therapeutics, Inc. seeks an Executive Director / Vice President of Data Management to establish and execute a global data-management strategy across its portfolio.

You will build a scalable, inspection-ready function delivering high-quality data for regulatory submissions and decision-making. Lead start-up through archival, partner with Clinical Operations, Biostatistics, Regulatory Affairs, and external vendors to ensure CDISC standards, data integrity, and timely delivery across multi-site