Director, Data Solutions – Optimization

Role Overview

• Lead and manage Data Solutions & Optimization, including clinical programming, EDC programming, data analytics, and visualization functions.
• Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
• Drive the development of technical initiatives, including EDC integration, participate in specification review &/or development of Spotfire visualizations, data currency and cleanliness metrics and visualizations, and other solutions in partnership with IT System Owner & other key stakeholders.
• Ensure the EDC platform is a qualified and validated system and manage the impact analysis of system updates, ensuring ongoing system optimization, risk mitigation, and cross-functional awareness.
• Lead data standards initiatives including data cleaning and reporting tools and standard CRFs and edit checks, ensuring alignment with current CDISC SDTM standards.
• Drive process improvements, workflow optimizations, and the development of new SOPs to enhance operational efficiency.
• Provide strategic oversight and support of high-priority projects, including database builds, freezes, and locks, user access management for data systems, and evaluation of system updates.
• Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
• Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
• Collaborate with other departments (i.e., IT, Clinical Operations, Clinical Science, etc.) to align data strategies with broader organizational goals and objectives.
• Function as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.

Requirements

• B.A./B.S. degree or higher (life-science-related fields preferred), or equivalent experience.
• 10+ years of progressive experience in data management within biotech/pharma, including at least 5 years in a leadership role.
• Proven history of leading Data Programming for global clinical trials across all phases.
• Direct operational experience as Data Programming Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
• Knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR.
• Experience in oversight of CRO programming resources and performance assessments (FSP oversight experience is a plus).
• Expertise in Data Governance Execution and Framework.
• Extensive knowledge of CDISC standards, including CDASH and SDTM.
• Experience in retina diseases and/or gene therapies is a plus.

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options