Prilenia

Vice President

• Lead the strategy, build-out, and execution of clinical data management across the company’s clinical development portfolio
• Ensure data supporting global marketing authorization applications are complete, accurate, consistent, and submission-ready
• Own data management planning, EDC systems, data standards, database lock, and CRO/vendor oversight
• Build and lead a fit-for-purpose data management team and establish SOPs, systems, and governance
• Serve as senior data management leader and subject matter expert for marketing authorization application preparations
• Develop and execute clinical data management strategy across ongoing and planned trials
• Lead end-to-end database lock planning and execution for pivotal trials
• Represent data management in FDA and other regulatory authority interactions and respond to regulatory review information requests
• Partner with Regulatory Affairs and Biostatistics on submission data packages, including SDTM, ADaM, define.xml, and reviewer’s guides
• Oversee Data Management Plans, CRF/eCRF design, edit check specifications, and data validation plans
• Ensure data cleaning, query management, SAE reconciliation, coding, external data reconciliation, and third-party data integration
• Establish and monitor data quality metrics and drive continuous improvement
• Ensure adherence to CDISC standards and compliance with 21 CFR Part 11, GDPR/HIPAA, and data privacy and security policies
• Manage CRO, EDC vendor, and specialty data vendor relationships, including scope, budget, timelines, and quality oversight
• Lead vendor selection and oversee vendor audits and resolution of findings
• Ensure compliance with ICH-GCP, FDA regulations, and company SOPs; maintain inspection-ready documentation
• Lead readiness for pre-approval inspections and sponsor audits, including mock inspections and CAPA management
• Maintain SOPs, working practices, training materials, and training compliance
• Manage hybrid internal/outsourced operating model, function budget, resourcing, and vendor spend
• Partner with Biostatistics, Statistical Programming, Clinical Operations, Quality, Regulatory Affairs, Pharmacovigilance, and other functions
• Report progress and risks to senior leadership and, as appropriate, the Board
• Contribute as data management subject matter expert in cross-functional, alliance management, and business development activities

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