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Director, TMF Operations

Remote

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 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%)

Salary range for posting

$200,000 - $225,000 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.

 

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