Director, Global Trial Master File

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

This role provides enterprise leadership for Trial Master File (TMF) strategy, governance, and execution across a global clinical portfolio and is accountable for end-to-end TMF operations, including oversight of internal teams, FSPs, CRO partners, and enabling technologies. The role ensures inspection readiness, regulatory compliance, and scalable operations while driving continuous improvement and modernization of TMF practices.

• Strategic Leadership & Governance:
  Define and lead the global TMF strategy, governance framework, and operating model
• Establish inspection-readiness standards aligned with ICH-GCP and global regulations
• Serve as escalation point for TMF risks, compliance issues, and inspection outcomes
• People Leadership:
  Lead and develop a global team of TMF professionals across regions and partners
• Drive workforce planning, capability building, and performance management
• Foster an inclusive culture of accountability, quality, and continuous improvement
• Operational Oversight:
  Ensure consistent TMF execution across studies, CROs, and regions
• Own KPIs, quality metrics, and timeliness of TMF deliverables
• Oversee TMF consolidation, archival, and retention strategies
• Inspection & Audit:
  Lead TMF support for regulatory inspections and internal audits
• Review findings, approve CAPAs, and ensure sustainable remediation
• Process & Innovation:
  Own global TMF SOPs, work instructions, and TMF Index Model
• Drive system optimization (e.g., Veeva Vault) and digital innovation
• Leverage automation and data insights to improve TMF quality and efficiency

• Degree (such as Bachelor’s) or equivalent experience required; advanced degree or equivalent preferred
• Significant experience in TMF or clinical document management (typically 8-10+ years, or equivalent experience)
• Experience managing global teams and vendors
• Strong knowledge of ICH-GCP and regulatory requirements
• Experience with eTMF systems (such as Veeva Vault, or similar systems)
• Familiarity with CDISC TMF Reference Model
• Strong leadership, communication, and problem-solving skills
• Experience in global, matrixed organizations
• Willingness to travel up to 20%, both domestic and international. Reasonable accommodations will be provided to support candidates with disabilities.