Director, Clinical Data Management

Experteer Overview As Director, Clinical Data Management you will lead data management operations across outsourced CDM activities, ensuring high-quality data for regulatory submissions and analyses. You will manage vendor relationships, drive study-level DM planning, and coordinate data deliverables with cross-functional teams. This role offers impact through shaping data management strategy for late-stage trials and supporting Xencor’s mission to advance high-potential therapeutics. Compensation / Benefits * Provide operational leadership for data management across studies and CROs from start-up to close-out * Oversee vendor evaluation, selection, budgeting, contracting, training and supervision for CDM services * Lead creation and review of DM plans, CRF guidelines, coding guidelines, annotated CRFs, and edit checks * Ensure standard, accurate, complete clinical databases and external data files for analyses and regulatory submissions * Coordinate review of clinical data, tables/listings/figures, and patient profiles for accuracy * Ensure data quality suitable for locking for clinical review and statistical analysis * Maintain study-specific files for data management auditability and reconstruction * Manage DM timelines and synchronization with overall project milestones * Provide training on CRF completion and EDC systems to investigators and project members * Support performance management of team members and adherence to company policies * Occasional travel between Pasadena and San Diego offices Tasks * BS in Life Sciences, Computer Sciences or Mathematics * minimum 12 years of related experience in data management in pharma/biotech * at least 5 years of data management experience in the industry * at least 5 years of people management experience * clinical trial experience across the full data management life cycle * good knowledge of ICH, FDA, and GCP regulations * strong technical skills including CDISC, STDM, MeDRA * understanding of data management technology and systems * competency in MS Office and other computer-based tools * ability to work cross-functionally and communicate effectively * leadership competencies per Xencor model * ability to coach and supervise staff * willingness for occasional travel Key requirements * 401k match * healthcare coverage * ESPP * annual bonus * equity grant

relationships, and patient profiles for accuracy * Ensure data quality suitable for locking for clinical review and statistical analysis * Maintain study-specific files for data management auditability and reconstruction * Manage DM timelines and synchronization with overall project milestones * Provide training on CRF completion and EDC systems to investigators and project members * Support performance management of team members and adherence to company policies * Occasional travel between Pasadena and San Diego offices Tasks * BS in Life Sciences, Computer Sciences or Mathematics * minimum 12 years of related experience in data management in pharma/biotech * at least 5 years of data management experience in the industry * at least 5 years of people management experience * clinical trial experience across the full data management life cycle * good knowledge of ICH, FDA, and GCP regulations * strong technical skills including CDISC, STDM, MeDRA * understanding of data management aaaa aaaaH_ and systems * competency in MS Office and other computer-based tools * ability to work cross-functionally and communicate effectively * leadership competencies per Xencor model * ability to coach and supervise staff * willingness for occasional travel Key requirements * 401k match * healthcare coverage * ESPP * annual bonus * equity grant