Senior Director, Data Management Systems

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Organizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: Reporting to the Vice President, Data Management, this position is responsible for providing strategic and operational leadership over the clinical data technology ecosystem, including eCOA/ePRO platforms, eDiary solutions, Medidata Rave (EDC), and Elluminate. This role is not directly responsible for hands-on clinical data management activities (e.g., data cleaning, query resolution, database lock); rather, it requires a strong clinical data management background to inform sound systems strategy, oversee system governance, and lead a team responsible for platform architecture, configuration, integration, and lifecycle management. The ideal candidate understands data management processes deeply enough to translate them into scalable, well-governed technology solutions, and brings proven experience leading systems teams. Serves as a key member of the Data Management Leadership Team, supporting cross-functional team needs and oversees the management of system related enhancements to support study deliverables. Interfaces with CROs and is responsible for managing internal Data Management team members. Key Responsibilities: Leadership & Management Lead, mentor, and develop a team of clinical trial solutions personnel Set systems strategy, roadmap, and performance metrics; conduct performance reviews and support career development. Manage systems related budget, resourcing, vendor contracts, and staffing plans across concurrent systems and study portfolios. Serve as a key member of the clinical data management leadership team, representing clinical systems in cross-functional governance forums. Partner with (but do not directly own) the data management operations team and vendors, ensuring systems strategy aligns with DM process needs. Clinical Systems Strategy & Governance Own the enterprise strategy, roadmap, and governance model for core clinical data systems, including: eCOA / ePRO platforms (patient/clinician-reported outcomes) eDiary systems Medidata Rave EDC Elluminate (data review, aggregation, and analytics platform) Define and maintain system governance frameworks: access management, role-based permissions, change control, and version control across platforms. Establish standards for system configuration, study build templates, and reusable libraries to drive consistency and efficiency across studies. Lead vendor management and contract oversight for all clinical systems vendors, including SLA definition, performance monitoring, and renewal/negotiation strategy. Own system-related budget planning, licensing decisions, and total cost of ownership analysis. System Implementation & Lifecycle Management Lead selection, evaluation, and implementation of new clinical systems and platform upgrades, including RFP processes and vendor due diligence. Oversee computer system validation (CSV/CSA) activities, ensuring systems meet 21 CFR Part 11, GxP, and data integrity requirements. Direct system configuration, build, and testing activities for EDC, eCOA, eDiary, and Elluminate environments. Manage the end-to-end lifecycle of clinical systems: onboarding, ongoing maintenance, periodic review, upgrades, and decommissioning/retirement/data archival. Establish and maintain disaster recovery, business continuity, and system uptime/performance standards in partnership with IT. Integration & Interoperability Lead architecture and oversight of system integrations (e.g., EDC-to-eCOA, EDC-to-Elluminate, EDC-to-IRT/RTSM/safety databases) to ensure seamless, accurate, and timely data flow. Partner with IT/technical teams to define data integration specifications, API/interface requirements, and data mapping standards. Troubleshoot and resolve systemic/integration-level issues, distinguishing systems-level root causes from data management process issues. Drive adoption of automation, AI-enabled tools, and dashboarding/analytics capabilities to improve data flow visibility and reduce manual effort. Compliance, Quality & Risk Ensure clinical systems remain inspection-ready at all times; serve as the systems SME during regulatory inspections and audits. Maintain SOPs, validation documentation, and system-level quality standards in partnership with Quality Assurance. Monitor emerging regulatory guidance (e.g., FDA, EMA, ICH E6(R3)) related to clinical technology and data integrity, and proactively adapt systems strategy accordingly. Own risk assessments related to system changes, upgrades, and vendor transitions. Cross-Functional Collaboration Serve as the primary systems liaison to Clinical Data Management, Biostatistics, Clinical Operations, Clinical Development, Regulatory, Quality, and IT. Provide systems and technology input into protocol development, study design feasibility, and technology selection at the program level. Educate and train clinical data management and cross functional staff on system capabilities, updates, and best practices. Required Qualifications Bachelor's degree in life sciences, health information, computer science, or related field (advanced degree preferred). 15+ years of progressive experience in clinical data management and/or clinical data systems within pharmaceutical, biotech, or CRO environments. Strong foundational background in clinical data management (data cleaning, query management, database lock, DM planning) — this role oversees systems, not day-to-day data management operations, but requires fluency in DM processes to inform systems decisions. 5+ years of people management experience, including managing managers or system-focused teams. Demonstrated experience owning or administering: eCOA/ePRO systems eDiary platforms Medidata Rave EDC Elluminate Strong knowledge of system validation (CSV/CSA), 21 CFR Part 11, ICH-GCP, and global regulatory requirements governing clinical data systems. Proven track record leading system implementations, upgrades, integrations, and vendor management. Experience supporting regulatory inspections and audits related to clinical systems and data integrity. Preferred Qualifications Experience across multiple therapeutic areas and trial phases (I–IV). Familiarity with additional clinical technologies (e.g., IRT/RTSM, CTMS, safety databases, eTMF). Experience with system integration architecture, APIs, and data pipeline/interface design. Certification in clinical data management (e.g., CCDM), IT/systems (e.g., ITIL), or project management (e.g., PMP). Experience with computer system validation methodologies and audit trail/data integrity frameworks. Skills & Competencies Strategic, technology-forward thinking paired with strong operational execution. Deep understanding of clinical data management principles, applied through a systems and governance lens. Excellent people leadership, coaching, and team-building skills. Strong vendor management, negotiation, and contract oversight capabilities. Ability to translate business/process needs into scalable technical solutions. Excellent written and verbal communication skills, including with technical and non-technical stakeholders. Comfortable operating in a fast-paced, matrixed organization. Work Environment: Remote-based Dynamic, interactive, fast-paced, and entrepreneurial environment Domestic or international travel are required (10-20%) Salary range for posting $260,000 — $290,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.