Associate Director Document Management and Trial Master File

Role Overview & Key Functions:

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.

• Key Responsibilities
  :

  Reporting to the Senior Director of Quality & Clinical Compliance (QCC)

  TMF Leadership & Oversight

  • 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.

  People Management & Development

  • 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.

  Vendor & Stakeholder Management

  • 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.

  TMF Quality, Metrics & Compliance

  • 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.

  Process Improvement & Documentation

  • 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.

  Qualifications:

  • 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.
  • Karyopharm operates two eTMF systems. Hands-on experience with Veeva Vault eTMF, including system configuration support, user management, reporting, and inspection readiness activities. Experience with Trial Interactive is beneficial.
  • 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.

At Karyopharm, we live and demonstrate our ICARE values every day!

Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.