Director, Clinical Data Management

Role: The Director, Clinical Data Management leads end-to-end data management activities for a new radiopharmaceutical oncology product, overseeing strategy, execution, quality, and cross-functional collaboration from study start-up to database lock and submission. Responsibilities include developing data management plans, overseeing CRO/vendor performance, ensuring high-quality, decision-ready data, and managing data review processes. The role requires close partnership with Clinical Operations, Biostatistics, Medical, and Regulatory teams to ensure data integrity and compliance. Requirements: Bachelor’s/Master’s in Life Sciences, Computer Science, or related field; 10+ years in pharma/biotech/CRO data management, with oncology experience preferred; strong knowledge of EDC systems (Medidata RAVE/Veeva), GCP, CDISC/CDASH, ICH, FDA regulations; excellent communication and analytical skills. Preferred: radiopharmaceutical experience. High-Value: Oncology (solid tumors), radiopharmaceutical modality, clinical stage (likely Ph1-3), GxP compliance, cross-functional leadership, AI-driven data strategies. Work setup: Remote US or onsite in San Diego, with ~10% travel. The role emphasizes solutions-oriented leadership, vendor oversight, and regulatory readiness.