Director, Data Management and Informatics

Role: Senior leader overseeing regulatory data management, informatics, and analytics functions critical to product lifecycle management in a biopharma setting. Objectives include delivering compliant, submission-ready data from IND through NDA/BLA, and post-approval activities, while developing scalable digital tools that enhance data accessibility, automation, and decision-making. Responsibilities encompass leading cross-functional teams supporting scientific, regulatory, and quality data systems, driving strategy, governance, and process improvements aligned with digital transformation goals. Qualifications: Bachelor's in Chemistry, Pharma, Biology, Data Science, or related with 15+ years (or Master's/Ph.D. with 10+ or 7+ years) of experience in data management, informatics, or regulatory CMC in regulated environments. Proven leadership, stakeholder engagement, and expertise in data integrity, regulatory processes, and enterprise system lifecycle management are required. Preferred skills include experience with regulatory submissions, application of analytics or AI/GenAI, and managing diverse scientific teams. High-value biopharma specifics: focus on regulatory data systems supporting IND through NDA/BLA stages, emphasizing compliance, inspection readiness, digital innovation, and enterprise data strategy. Collaboration spans Analytical Development, Regulatory CMC, Quality, Digital, R&D, and Manufacturing divisions. Work setup is hybrid with approximately 10% travel.