Associate Director Document Management and Trial Master File

divh2Associate Director, Document Management and Trial Master File (TMF) / h2pThe 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. / ph3Candidate Profile Requirements : / h3pstrongKey Responsibilities : / strong / pulliProvide leadership and oversight for day-to-day TMF / eTMF operations across all clinical studies. / liliEnsure TMFs are created, maintained, and archived in compliance with Karyopharm SOPs, ICH-GCP, FDA, EMA, and other applicable regulatory requirements. / liliEnsure TMFs are inspection-ready at all times and support internal and external audits and health authority inspections. / liliServe as TMF subject matter expert and escalation point. / li / ulpstrongPeople Management Development : / strong / pulliManage, coach, and develop TMF staff (e.g., TMF Managers, Coordinators, Documentation Specialists). / liliSupport hiring, onboarding, training, and performance management of TMF team members. / liliFoster a culture of quality, accountability, collaboration, and continuous improvement. / liliContribute to the development and delivery of TMF training programs for TMF staff and cross-functional teams. / li / ulpstrongVendor Stakeholder Management : / strong / pulliProvide oversight of TMF vendors, including performance monitoring, issue resolution, and regular governance meetings. / liliCollaborate with vendors to ensure efficient and compliant use of eTMF systems. / liliPartner closely with Clinical Operations, Quality, Regulatory, Pharmacovigilance, Data Management, Pharmaceutical Science, Drug Supply, and other stakeholders to ensure alignment on TMF expectations and deliverables. / liliServe as a key TMF contact for internal and external stakeholders. / li / ulpstrongTMF Quality, Metrics Compliance : / strong / pulliDefine, review, and analyze TMF quality and performance metrics to assess completeness, timeliness, and inspection readiness. / liliReview vendor-provided metrics and follow up on trends, risks, and corrective actions as needed. / liliConduct or oversee TMF QC checks, gap analyses, and remediation activities. / liliInitiate and support corrective and preventive actions (CAPAs) related to TMF quality issues. / li / ulpstrongProcess Improvement Documentation : / strong / pulliIdentify inefficiencies, risks, and opportunities for improvement in TMF processes and workflows. / liliContribute to the development, maintenance, and continuous improvement of TMF SOPs, work instructions, and templates. / liliSupport implementation of industry best practices, including alignment with the DIA TMF Reference Model. / liliParticipate in cross-functional initiatives and departmental process improvement efforts. / li / ulpstrongQualifications : / strong / pulliBachelors degree is required in life science, biomedical, or related field. / liliMinimum 710 years of experience in TMF / eTMF management within a pharmaceutical, biotechnology, or CRO environment. / liliStrong working knowledge of ICH-GCP, FDA, EMA, and global TMF regulatory requirements. / liliSolid understanding of the CDISC TMF Reference Model. / liliKaryopharm operates two eTMF systems. Hands-on experience with Veeva Vault eTMF, including system configuration support, user management, reporting, and inspection readiness activities. Experience with TrialInteractive is beneficial. / liliDirect experience supporting regulatory authority inspections and audits (e.g., FDA, EMA), including TMF preparation, health authority interactions, inspection responses, and remediation activities. / liliDemonstrated experience managing and coaching direct reports. / liliExperience overseeing TMF vendors and managing vendor performance. / liliProven ability to develop, analyze, and utilize operational and quality TMF metrics. / liliStrong organizational, analytical, and problem-solving skills. / liliExcellent communication skills with the ability to effectively interact at all levels of the organization. / liliAbility to manage competing priorities in a fast-paced, dynamic environment. / liliHigh level of attention to detail with a strong commitment to quality and compliance. / liliComfortable with technology and experienced navigating multiple eTMF systems. / li / ulh3Our Value Proposition : / h3pAt Karyopharm, we live and demonstrate our ICARE values every day! / ppKaryopharm 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. / p / div