Director, Data Management and Informatics

Role: Lead a critical organization overseeing regulatory data management, informatics, and digital solutions to support scientific and regulatory activities across the product lifecycle, from IND to post-approval. Objectives include delivering accurate, compliant regulatory data, advancing analytics and visualization capabilities, and enabling data-driven decision-making. Responsibilities encompass strategic leadership of enterprise data systems, standardization, automation, and ensuring inspection readiness, while partnering with cross-functional teams in Analytical Development, Regulatory CMC, Quality, Digital, R&D, and Manufacturing. Qualifications: Bachelor's degree in a relevant scientific or technical discipline with at least 15 years (or Master's with 10+ years, Ph.D. with 7+) of experience in data management, informatics, or related regulated environments; proven leadership in digital transformation initiatives; strong stakeholder management and strategic thinking skills. Preferred: Experience supporting regulatory submissions, managing diverse teams, applying analytics to scientific data workflows, and knowledge of emerging digital technologies like AI/GenAI. High-Value: Expertise in regulatory CMC data, digital solutions, compliance, inspection readiness, and cross-functional collaboration in a regulated biopharma setting. Work setup: hybrid, with 10% travel.