Associate Director, Data Management

Role: Associate Director of Clinical Data Management leading data activities for rare disease programs, focusing on chronic neutropenic disorders such as WHIM syndrome. Responsibilities: oversee all data management from protocol to database lock, develop strategies supporting timelines and regulatory readiness, manage CROs/vendors, ensure data quality and inspection preparedness, and collaborate cross-functionally to support clinical trial success. Requirements: 8+ years in clinical data management in biotech/pharma or CROs; 3+ years leadership experience managing vendor relationships; supporting Phase 2/3 and regulatory submissions; strong knowledge of ICH-GCP, FDA/EMA regulations, CDISC standards, and risk-based quality principles. Preferred: experience in rare diseases. HighValue: rare disease focus, biologics/clinical data, regulatory compliance, vendor oversight, cross-functional collaboration, hybrid work in Boston with some onsite presence.