Director, Clinical Data Management

Role: Senior leader overseeing clinical data management (CDM) for multiple therapeutic areas in a biopharma setting focused on neurodegenerative diseases and related disorders. Objectives: ensure high-quality, compliant data collection and management across clinical trial phases (P1-P3), support regulatory submissions, and implement process improvements. Responsibilities: lead CDM strategy and team management, collaborate with cross-functional teams (Clinical Operations, Biostatistics, Data Science), oversee systems and vendor performance, and maintain regulatory compliance with FDA, EMA standards. Qualifications: BA/BS in science or health-related field; 10+ years of CDM experience including 5+ years in managerial roles within biotech/pharma, with expertise in data standards (CDISC, SDTM), EDC systems, and vendor oversight. Preferred: experience supporting regulatory submissions (NDAs, BLAs), familiarity with non-CRF data flows and drug development lifecycle. High-value: leadership in complex clinical trials (pivotal, randomized, blinded), focus on process automation and systems enhancement, GxP compliance, and global regulatory readiness. Work setup: likely hybrid or onsite, with expectations for cross-departmental collaboration and vendor management.