Senior Director, Data Management Systems

Job description

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.