The Director, TMF Operations oversees the transformation and management of Trial Master Files, ensuring compliance and inspection readiness across clinical studies, while mentoring staff and partnering with cross-functional teams.
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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