Position Overview

The Director, Clinical Development Systems (CDS) provides strategic and operational leadership of Immunome’s clinical systems, responsible for advancing the Development function’s systems strategy, roadmap, and implementation plans, including Trial Master File (TMF), Clinical Trial Management System (CTMS), reporting, AI-enabled dashboards, and KPI analytics.    

The Director partners with Development teams, IT, Quality, Procurement, Finance, and external vendors to establish connected, inspection-ready, and business-aligned clinical systems capabilities to enable end-to-end visibility across studies, countries, sites, milestones, documents, issues, risks, clinical monitoring activities, enrollment, cycle times, and trial performance indicators.   

The Director will also lead a high-performing CDS team to partner with Study Teams on trial delivery, oversee day-to-day vendor management, and establish clinical systems best practices.   

Responsibilities

Clinical Development   

• Serve as a clinical systems leader for the Development function, providing operational input on technology strategy, enterprise platforms, delivery options, and vendor solutions. 
• Develop and maintain the multi-year systems roadmap, aligning systems investments to business priorities, regulatory compliance, patient impact, and measurable value. 
• Recommend and establish governance forums for clinical systems programs, contributing to prioritization, scope and risk management, adoption, and sustainment. 
• Champion AI-enabled dashboards and advanced analytics that provide actionable insights into portfolio health, site performance, monitoring quality, TMF health, issue resolution, and operational risk, etc. 
• Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization for the CDS portfolio.  

Clinical Systems Delivery   

• Lead cross-functional planning and delivery of TMF and CTMS implementation and modernization, including business process design, configuration, data migration, integration validation, training, adoption, and change management.  
• Deliver a connected clinical operations ecosystem improving visibility across studies and spanning study start-up, enrollment, monitoring, milestones, protocol deviations, TMF health, inspection readiness, to closeout. 
• Partner with data and analytics leaders to define trusted KPIs, data sources, quality standards, access controls, reporting needs, and scalable dashboards for executive, functional, study, and operational teams.  
• Identify and sponsor opportunities to simplify manual tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.  

Vendor Management  

• Lead vendor and platform selection, including RFPs, systems evaluations, and business case development. 
• Oversee day-to-day management of vendors, ensuring vendor compliance with contractual obligations, timelines, and performance metrics.  

Quality and Regulatory Compliance  

• Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements. 
• Partner with Quality Assurance on system validation, inspection-readiness, audits and regulatory inspections, and corrective actions.  
• Drive operational excellence to ensure data integrity.   

Budget and Resource Management  

• Maintain financial oversight of CDS budgets and resource planning for a growing portfolio.  
• Build, lead, and mentor a high-performing CDS team, including Business Analysts, Business Owners, Systems Administrators. 
• Provide direction and support to project teams, partner resources, and vendor teams supporting Development’s technology initiatives.  
• Promote a culture of innovation, excellence, data integrity, inspection readiness, and continuous improvement.   

Qualifications 

• Bachelor’s degree or equivalent experience with 12+ years in technology leadership, clinical systems, business analysis, product ownership, clinical operations technology, or technology program leadership within the biotech/pharma industry; or higher degree with 10+ years of relevant experience.
• Experience leading technology solutions, enterprise platforms, or technology portfolios including GxP systems.  
• Experience implementing and optimizing Clinical Development capabilities, particularly eTMF, CTMS implementations and related integrations. 
• Experience delivering dashboards, predictive insights, automation, and decision-support tools.  
• Experience supporting internal audits, regulatory inspections, inspection-readiness activities, CAPA, and evidence preparation for validated clinical systems. 
• Experience integrating clinical systems such as CTMS, eTMF, EDC, safety, regulatory, site payments, study start-up, data warehouse, analytics, or reporting platforms. 

Knowledge and Skills

• Strong stakeholder management, communication, and influencing skills across business, technical, quality, and vendor audiences, including senior leadership. 
• Demonstrated ability to translate business needs into technology strategies, business cases, process improvements, and measurable outcomes.  
• Financial acumen for technology portfolio leadership (budget planning, investment prioritization, forecasting, and value realization).  
• High degree of domain knowledge of clinical development and clinical trial operations.  
• Expertise in delivering technology programs using Agile, product management, business analysis, business process analysis, and hybrid delivery methodologies. 
• Deep understanding of system development life cycle, computer system validation, data integrity, audit trails, electronic records/electronic signatures, and GxP, FDA, ICH regulated system implementation practices. 
• Demonstrated ability to lead through ambiguity, influence without direct authority, develop talent, and deliver measurable business impact with a high degree of professionalism, adaptability, and accountability.