Senior Director, Trial Master File (TMF) Operations

Madrigal Pharmaceuticals • Conshohocken, PA

2d • $308

About The Position

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Job Description We are seeking a Senior Director of Trial Master File (TMF) Operations. This is a newly created position which will play an important role in the continued growth and development of Madrigal’s Research and Development Department. Summary of Job Highlights This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of an in-house TMF document management system to support the Research and Development (R&D) Department. This position is responsible for cross-functional collaboration to ensure proper implementation, execution and alignment with companies' goals, culture, and vision. This role is accountable to develop document collection strategies and develop SOPs, training, and overall process to ensure the TMF health and archival of clinical trial documents from both external and internal sources.

Requirements

• Bachelor's Degree or higher
• 15+ years experience successfully leading the TMF activities for a clinical research organization (CRO) and/or in the biotech/pharmaceutical industry; other relevant experience will be considered
• Leadership skills and experience managing employees and contractors
• Experience with Veeva eTMF platform, strongly preferred
• Experience with CDISC Trial Master File Reference model and good understanding of records management best practices
• Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA
• Experience with Inspection Readiness
• Hands-on experience in a regulatory body inspection, strongly preferred
• Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
• Excellent attention to accuracy and details
• Effective written and verbal communication skills
• Excellent presentation skills, providing information to a large audience
• Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook)
• Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment
• Ability to learn new technologies with ease
• Solid analytical and proactive problem-solving skills
• Strong operational skills and demonstrated ability to meet timelines
• A team player with ability to build relationships at all levels
• Demonstrated self-starter with a high level of commitment

Responsibilities

• Provide leadership and strategic direction across the R&D Department, with specific focus on the Clinical Management Department, to ensure the TMF processes and related documentation are of the highest quality for active in-house and outsourced studies by drawing experience w/ quality compliance processes and regulations such as Good Clinical & Documentation Practices
• Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available)
• Develop standard reporting for ongoing compliance check by study to be presented at the Clinical study team meetings and to management
• Grow and lead a team of direct reports, commensurate with the business requirements, that will support the TMF platforms and each study TMF
• Develop proactive approaches to process improvements and enhancements of TMF
• Author and review internal and external TMF-related SOPs, work instruction development and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.) including working with the cross functional study team to obtain necessary input
• Ensure inspection ready TMF and provide expert support for audits and inspections
• Instill a culture of continuous improvement; acts as a change champion and effectively leads change
• Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies
• Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors
• Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents
• Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
• Support study teams at the end of trial eTMF QC and migration activities, including study documents from all vendors
• Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance
• Ad hoc support of activities within the Clinical Management team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed
• Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes
• Other duties as assigned

Benefits

• Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
• Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
• Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
• In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
• The company also provides other benefits in accordance with applicable federal, state, and local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees