Director, Global Trial Master File

Job Summary (Primary Function)

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.

Essential Functions Of The Job (Key Responsibilities)

• 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

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree (such as Bachelor’s) or equivalent experienced required; advanced degree or equivalent experience 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

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: http://www.incyte.com/privacy-policy