Director Data Management

Role: Director of Clinical Data Management leading data strategy and operations across Avalo's clinical programs, supporting IL-1β pathway therapeutics in immune-mediated inflammatory diseases. Responsibilities: oversee all data management activities, develop strategies aligning with clinical/regulatory needs, manage CROs and vendors, ensure high-quality, inspection-ready data, review key study documentation, support regulatory submissions, and build scalable processes. Requirements: BS/BA in Life Sciences, Engineering, or related; 12+ years (MS) or 15+ years (BS) in clinical data management within biotech/pharma/CRO settings; 5+ years in leadership; extensive experience with Phase I-III clinical trials, external vendor oversight, and data standards (CDISC, GCP, ICH, FDA). Skills: proficiency with EDC systems like Medidata Rave, Veeva, Oracle; knowledge of RBQM and global regulatory requirements. High-Value: focus on immune-oncology, biologics (anti-IL-1β mAbs), Phase 1-3 trials, regulatory support, GxP practices, and cross-functional collaboration with Clinical Ops, Biostatistics, Regulatory, and PV teams. WorkSetup: not specified; likely hybrid or remote based on industry standards.