Associate Director, Clinical Data Management
Core
Lead clinical data strategy and execution for gene editing programs from first-in-human studies through regulatory submission, ensuring data integrity and regulatory readiness.
Role type
Associate Director, Clinical Data Management
Builds
Clinical data packages for INDs, CTAs, BLAs, and global regulatory filings
Domain
Biotechnology / Gene Editing / Rare Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management leadership, CDISC standards (SDTM/ADaM), EDC systems, medical coding (MedDRA/WHO Drug), vendor oversight, regulatory inspection readiness, rare disease trial design, genomic data integration, PK/PD data management
Preferred skills
Gene therapy/gene editing experience, advanced degree in life sciences/statistics/informatics, dose-escalation study experience
Technologies
EDC, ePRO, IRT, CDISC, eCTD
Responsibilities
Lead clinical data management activities across multiple programs from IND through BLA submission; Develop and execute data management strategies aligned with regulatory requirements; Oversee CRF design, database build, edit checks, data review, coding, reconciliation, and database lock; Lead selection, oversight, and performance management of CRO and data management vendors; Oversee integration of complex data streams including genomic, biomarker, immunogenicity, and safety data
Seniority
Senior, hands-on IC with leadership responsibility
