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Director, TMF Operations

2 weeks ago
United States
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Immunovant

Immunovant

Pharmaceuticals
51-250
Founded 2018
$725M raised
View All Jobs 3

Description

  • Lead the TMF operating model, including strategy, governance, standards, and portfolio support.
  • Define and implement TMF processes, standards, KPIs, and risk-based oversight to ensure consistency, quality, and compliance.
  • Oversee TMF across all programs in alignment with ICH-GCP, the TMF Reference Model, and global regulatory expectations.
  • Lead TMF oversight in an outsourced model and hold CROs and vendors accountable for completeness, quality, timeliness, and reporting.
  • Establish TMF health metrics, risk indicators, escalation pathways, dashboards, and governance reporting for senior leadership.
  • Serve as the TMF subject matter expert for cross-functional teams and support role-based training and adoption monitoring.
  • Lead and support TMF activities for health authority inspections, QA audits, and inspection readiness preparation.
  • Drive remediation and CAPA development for TMF-related inspection findings.
  • Lead eTMF system strategy and governance, including taxonomy, metadata standards, mapping, reconciliation, validation, change control, and UAT.
  • Drive TMF quality improvement, support staff and vendor capability building, manage TMF migrations and system implementations, and embed TMF expectations into contracts and SOWs.

Requirements

  • BS/BA degree required; advanced degree highly desirable.
  • 8–12+ years of clinical research experience, including significant TMF/eTMF leadership experience.
  • Proven experience building and leading TMF frameworks in an outsourced or hybrid operating model.
  • Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections, including FDA and EMA.
  • Strong knowledge of ICH-GCP, the TMF Reference Model, and global regulatory requirements.
  • Extensive experience with eTMF systems such as Veeva Vault TMF or equivalent, including governance and optimization.
  • Experience managing CROs and vendors and holding them accountable for TMF quality and delivery.
  • Excellent communication skills and ability to represent TMF in regulatory-facing settings.
  • Demonstrated excellence in complex project management and managing multiple priorities.
  • Ability to solve problems with innovative solutions and strong organizational skills.
  • Demonstrated ability to lead cross-functional initiatives and influence at a senior level.
  • Strong leadership, strategic thinking, and decision-making skills.
  • Experience with remote work and up to 10% domestic travel required.

Benefits

  • Salary range of $200,000 to $225,000 USD.
  • Potential equity and other forms of compensation as part of total pay.
  • Medical, dental, and vision coverage.
  • 401(k) benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Remote work arrangement.

Interested in this position?

Apply directly on the company website

Apply Now

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