Karyopharm Therapeutics Inc. · 3 days ago
Associate Director Document Management and Trial Master File
Newton, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expKaryopharm Therapeutics Inc. is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs. 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 across clinical programs, ensuring TMFs are complete, accurate, and inspection-ready while leading TMF staff and overseeing vendors.
Health CareMedicalPharmaceutical
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
Qualification
Required
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
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
Preferred
Experience with TrialInteractive is beneficial
Company
Karyopharm Therapeutics Inc.
Karyopharm Therapeutics Inc.
201-500 employees
H1B Sponsorship
Karyopharm Therapeutics Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (2)
2023 (10)
2022 (8)
2021 (5)
2020 (10)
Funding
Current Stage
Public CompanyTotal Funding
$607.2MKey Investors
Avidity PartnersForesite CapitalDelphi Ventures
2025-10-08Post Ipo Equity· $33M
2025-10-08Post Ipo Debt· $27.5M
2022-12-05Post Ipo Equity· $165M
Leadership Team
Brian Austad
Senior Vice President, Pharmaceutical Sciences
Sohanya Cheng
EVP, Chief Commercial Officer & Head of Business Development
Recent News
2025-11-08
Company data provided by crunchbase