Director, TMF Operations

The Role:

Reporting to the Senior Director of Clinical Operations, the Director, TMF Operations leads Immunovant’s TMF transformation and ongoing TMF operations to deliver a governed, inspection-ready TMF operating model. The role will drive TMF strategy, quality, oversight, and inspection readiness, including TMF governance, a harmonized Sponsor TMF definition across systems and partners, and a CRO model that demonstrates sponsor oversight. The Director drives the shift to process-centric TMF management by embedding TMF outputs into core clinical processes, implementing risk-based oversight, and delivering KPIs and dashboards for completeness, timeliness, and risk. This role partners with Clinical Operations, Quality/Compliance, Regulatory, IT/eTMF, Alliance Management, and Procurement/Legal to ensure compliant processes, systems, training, and documentation.

Key Responsibilities:

• Lead the TMF operating model, including strategy, governance, standards, and operating model to support portfolio
• Define and implement TMF processes, standards, and KPIs to promote consistency, quality, and compliance across studies and vendors utilizing a risk-based approach to ensure sponsor oversight
• Oversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations
• Lead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadership
• Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies
• Serve as the TMF subject matter expert, guiding cross-functional teams, influencing best practices, supporting role-based training for sponsor and CRO teams, and monitoring adoption and uptake through metrics and governance
• Lead and support TMF-related activities for health authority inspections (FDA, EMA, and other regulatory agencies)
• Drive continuous inspection readiness by defining, implementing and improving the TMF/eTMF operating model and performance program
• Serve as TMF lead/SME for TMF-related inspections and QA audit activities
• Drive TMF inspection preparation, SME briefing, document retrieval, and response coordination including TMF demonstrations, evidence packages and remediation planning
• Lead or support remediation and CAPA development for TMF-related inspection findings
• Drive eTMF system strategy and governance, including:
• System configuration, taxonomy, and metadata standards
• Lead cross system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory and QMS to support trial reconstruction
• Vendor/system performance and optimization
• Partner with CBO Ops, IT and quality systems on validation and change control for eTMF and related systems, as applicable
• Oversight of enhancements, releases, and UAT
• Drive TMF quality at scale by:
• Establishing QC/QR frameworks and oversight models
• Driving effective TMF reconciliation practices across functions and vendors
• Identifying systemic gaps and implementing continuous improvement initiatives
• Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building
• Partner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to drive end-to-end TMF alignment
• Lead and support TMF-related risk management, including proactive identification and mitigation of compliance risks
• Lead or support TMF migrations, system implementations, and vendor transitions
• Partner with Procurement/Legal and Alliance Management to embed TMF expectations in contracts and SOWs (access, reporting, audit rights, inspection support)

Requirements:

• BS/BA degree required, advanced degree highly desirable
• 8–12+ years of clinical research experience, including significant TMF/eTMF leadership experience
• Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model
• Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)
• Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
• Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization
• Experience managing CROs/vendors and holding them accountable for TMF quality and delivery
• Excellent communication and ability to represent TMF in regulatory-facing settings
• Demonstrated excellence in complex project management and effective management of multiple projects/priorities
• Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Demonstrated ability to lead cross-functional initiatives and influence at a senior level
• Strong leadership, strategic thinking, and decision-making skills

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• The position is for remote work
• Domestic travel required (up to 10%)