Trial Master File Job Jobs (NOW HIRING)

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.
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.
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Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
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