Director, Global Trial Master File

Director, Global Trial Master File

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.

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. Reasonable accommodations will be provided to support candidates with disabilities.

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.