Director, Clinical Development Systems

Experteer Overview As Director, Clinical Development Systems, you will lead Immunome’s clinical systems strategy and delivery to enable end-to-end visibility across studies, sites, and regulatory milestones. You will partner with Development, IT, Quality, and external vendors to build inspection-ready, connected systems (TMF, CTMS, dashboards) that drive portfolio health and operational excellence. You will mentor a CDS team and oversee vendor management, governance, and data integrity initiatives. This role offers the chance to shape how clinical operations are powered by data and analytics at a fast-growing biotech. Compensation / Benefits * Provide strategic and operational leadership for clinical systems within Development (TMF, CTMS, dashboards, analytics) * Develop and maintain a multi-year systems roadmap aligned to priorities, compliance, and value * Establish governance for clinical systems programs and drive adoption and sustainment * Champion AI-enabled dashboards and analytics for portfolio health, site performance, TMF health, and risk monitoring * Manage budgets, vendor delivery, and strategic sourcing for CDS portfolio * Lead TMF and CTMS delivery and modernization (process design, data migration, integration, training, change management) * Create connected, compliant clinical operations ecosystem across studies and milestones * Define KPIs, data sources, access controls, and scalable reporting for executives and teams * Identify opportunities to automate processes, reduce manual data entry, and strengthen data integrity * Oversee vendor management and platform evaluations, including RFPs and business cases * Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements, including inspection readiness and audits * Build and mentor a high-performing CDS team and promote innovation, data integrity, and continuous improvement * Provide direction to project teams, partner resources, and vendor teams supporting Development technology initiatives Tasks * Bachelor’s degree or equivalent with 12+ years in technology leadership or clinical systems within biotech/pharma, or higher degree with 10+ years of relevant experience * Experience leading technology solutions or enterprise platforms including GxP systems * Experience implementing eTMF, CTMS implementations, and related integrations * Experience delivering dashboards, predictive insights, automation, and decision-support tools * Experience supporting internal audits, regulatory inspections, CAPA, and validated clinical systems evidence * Experience integrating clinical systems such as CTMS, eTMF, EDC, safety, regulatory, site payments, data warehouse, analytics, or reporting platforms * Strong stakeholder management, communication, and influencing across senior leadership and cross-functional teams * Financial acumen for technology portfolio leadership (budgeting, forecasting, value realization) * Deep domain knowledge of clinical development and trial operations * Expertise in Agile, product management, business analysis, and hybrid delivery methodologies * Knowledge of computer system validation, data integrity, audit trails, electronic records/electronic signatures, and GxP/regulatory practices Key requirements *

Tasks * Bachelor’s degree or equivalent with 12+ years in technology leadership or clinical systems within biotech/pharma, or higher degree with 10+ years of relevant experience * Experience leading technology solutions or enterprise platforms including GxP systems * Experience implementing eTMF, CTMS implementations, and related integrations * Experience delivering dashboards, predictive insights, automation, and decision-support tools * Experience supporting internal audits, regulatory inspections, CAPA, and validated clinical systems evidence * Experience integrating clinical systems such as CTMS, eTMF, EDC, safety, regulatory, site payments, data warehouse, analytics, or reporting platforms * Strong stakeholder management, communication, and influencing across senior leadership and cross-functional teams * Financial acumen for technology portfolio leadership (budgeting, forecasting, value realization) * Deep domain knowledge of clinical development and trial operations * Expertise in a aaaL_ product management, business analysis, and hybrid delivery methodologies * Knowledge of computer system validation, data integrity, audit trails, electronic records/electronic signatures, and GxP/regulatory practices Key requirements *