Associate Director Document Management and Trial Master File

Karyopharm Therapeutics • Newton, MA

35d

About The Position

The Associate Director, Document Management and Trial Master File (TMF) provides strategic and operational leadership for the management of GxP Documents in the Trial Master Files (TMF/eTMF) across Karyopharm clinical programs. This role is responsible for ensuring TMFs are complete, accurate, and inspection-ready, while leading TMF staff, overseeing vendors, driving process improvement, and partnering cross-functionally to support successful study execution. The Associate Director serves as a subject matter expert for TMF processes and contributes to the continuous evolution of TMF strategy, quality, and compliance.

Requirements

• Bachelor’s degree is required in life science, biomedical, or related field.
• Minimum 7–10 years of experience in TMF/eTMF management within a pharmaceutical, biotechnology, or CRO environment.
• Strong working knowledge of ICH-GCP, FDA, EMA, and global TMF regulatory requirements.
• Solid understanding of the CDISC TMF Reference Model.
• Hands-on experience with Veeva Vault eTMF, including system configuration support, user management, reporting, and inspection readiness activities.
• Direct experience supporting regulatory authority inspections and audits (e.g., FDA, EMA), including TMF preparation, health authority interactions, inspection responses, and remediation activities.
• Demonstrated experience managing and coaching direct reports.
• Experience overseeing TMF vendors and managing vendor performance.
• Proven ability to develop, analyze, and utilize operational and quality TMF metrics.
• Strong organizational, analytical, and problem-solving skills.
• Excellent communication skills with the ability to effectively interact at all levels of the organization.
• Ability to manage competing priorities in a fast-paced, dynamic environment.
• High level of attention to detail with a strong commitment to quality and compliance.
• Comfortable with technology and experienced navigating multiple eTMF systems.

Nice To Haves

• Experience with TrialInteractive is beneficial.

Responsibilities

• Provide leadership and oversight for day-to-day TMF/eTMF operations across all clinical studies.
• Ensure TMFs are created, maintained, and archived in compliance with Karyopharm SOPs, ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
• Ensure TMFs are inspection-ready at all times and support internal and external audits and health authority inspections.
• Serve as TMF subject matter expert and escalation point.
• Manage, coach, and develop TMF staff (e.g., TMF Managers, Coordinators, Documentation Specialists).
• Support hiring, onboarding, training, and performance management of TMF team members.
• Foster a culture of quality, accountability, collaboration, and continuous improvement.
• Contribute to the development and delivery of TMF training programs for TMF staff and cross-functional teams.
• Provide oversight of TMF vendors, including performance monitoring, issue resolution, and regular governance meetings.
• Collaborate with vendors to ensure efficient and compliant use of eTMF systems.
• Partner closely with Clinical Operations, Quality, Regulatory, Pharmacovigilance, Data Management, Pharmaceutical Science, Drug Supply, and other stakeholders to ensure alignment on TMF expectations and deliverables.
• Serve as a key TMF contact for internal and external stakeholders.
• Define, review, and analyze TMF quality and performance metrics to assess completeness, timeliness, and inspection readiness.
• Review vendor-provided metrics and follow up on trends, risks, and corrective actions as needed.
• Conduct or oversee TMF QC checks, gap analyses, and remediation activities.
• Initiate and support corrective and preventive actions (CAPAs) related to TMF quality issues.
• Identify inefficiencies, risks, and opportunities for improvement in TMF processes and workflows.
• Contribute to the development, maintenance, and continuous improvement of TMF SOPs, work instructions, and templates.
• Support implementation of industry best practices, including alignment with the DIA TMF Reference Model.
• Participate in cross-functional initiatives and departmental process improvement efforts.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees