Director, Global Trial Master File

Overview A global biopharmaceutical company on a mission to solve unmet medical needs, Incyte follows science to develop proprietary therapeutics. The company has a portfolio of first‑in‑class medicines and a strong pipeline in Hematology, Oncology, Inflammation, and Autoimmunity. Headquartered in Wilmington, Delaware, Incyte operates in North America, Europe, and Asia. Job Summary The Global Trial Master File (TMF) Lead provides enterprise leadership for TMF strategy, governance, and execution across a global clinical portfolio. The role is accountable for end‑to‑end TMF operations, ensuring inspection readiness, regulatory compliance, and scalable, continuously improving practices. Essential Functions – 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 an 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 Degree such as a Bachelor’s or equivalent experience required; advanced degree or equivalent experience preferred. Significant experience in TMF or clinical document management (typically 8–10+ years). Experience managing global teams and vendors. Strong knowledge of ICH‑GCP and regulatory requirements. Experience with eTMF systems such as Veeva Vault or similar. Familiarity with the CDISC TMF Reference Model. Strong leadership, communication, and problem‑solving skills. Experience in global, matrixed organizations. Willingness to travel up to 20% (domestic and international). Reasonable accommodations will be provided to support candidates with disabilities. Incyte Corporation is an equal opportunity employer. We respect your privacy and are committed to creating a diverse environment for all employees. #J-18808-Ljbffr Incyte