Director, TMF Operations

Immunovant

Director, TMF Operations leading TMF transformation and operations at Immunovant, Inc. Driving TMF strategy, compliance, and governance for clinical trials.

Posted 5/12/2026full-timeRemote • 🇺🇸 United StatesLead💰 $200,000 - $225,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

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

What you’ll need

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)
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

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) plan
Unlimited paid time off
Parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

TMF processesTMF standardsKPI developmentTMF governanceeTMF systemsTMF strategyTMF quality managementproject managementrisk managementCAPA development

Soft Skills

leadershipstrategic thinkingdecision-makingcommunicationproblem-solvingorganizational skillsinfluencingmentoringcollaborationadaptability

Certifications

BS/BA degreeadvanced degree (highly desirable)