Associate Director, Trial Master File Operations

Madrigal Pharmaceuticals•Waltham, PA

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. The Associate Director (AD) TMF Operations will be responsible for leading day-to-day TMF operational strategy, oversight, inspection readiness, sponsor QC oversight, metrics management, issue escalation, and governance across the TMF operating model. This role will ensure that TMF processes are consistently executed, inspection-ready, and aligned with regulatory expectations, internal standards, study needs, and sponsor oversight obligations. This individual will serve as the primary business owner for TMF operational quality and will manage FSP resources supporting TMF activities. The role requires strong TMF expertise, disciplined execution, vendor oversight capability, inspection readiness experience, and the ability to drive consistent performance across studies, teams, and partners.

Requirements

Bachelor’s degree required; degree in life sciences, health sciences, clinical research, or related field preferred.
Strong experience in TMF operations, eTMF oversight, clinical documentation, clinical operations, or inspection readiness.
Experience managing or overseeing FSP, CRO, or vendor-supported TMF activities.
Strong knowledge of GCP, essential records, inspection readiness, sponsor oversight, and TMF health expectations.
Experience with eTMF systems required; Veeva Vault eTMF experience strongly preferred.
Familiarity with the CDISC TMF Reference Model preferred.
Experience developing or managing TMF metrics, QC processes, issue logs, remediation plans, and governance materials.
Strong organizational, communication, escalation, and stakeholder management skills.
Ability to manage competing priorities across studies, vendors, and internal stakeholders.
Inspection, audit, or health authority readiness experience strongly preferred.

Nice To Haves

Veeva Vault eTMF experience strongly preferred.
Familiarity with the CDISC TMF Reference Model preferred.
Inspection, audit, or health authority readiness experience strongly preferred.

Responsibilities

Lead TMF operations across assigned studies, programs, or the enterprise TMF model to support complete, accurate, timely, and inspection-ready documentation
Manage and oversee FSP TMF resources, including workload management, performance expectations, issue resolution, quality review, and escalation of operational risks
Establish and maintain consistent TMF QC oversight processes, including sponsor QC review, sampling strategy, quality issue tracking, and remediation follow-up
Monitor TMF health, completeness, timeliness, quality, and inspection readiness metrics to identify trends, risks, and corrective actions
Lead TMF operations, ensuring documentation is complete, accurate, timely, and inspection-ready.
Lead or support periodic TMF reviews, risk-based QC activities, completeness assessments, and inspection-readiness reviews.
Ensure TMF processes align with the TMF Plan, study milestones, the CDISC TMF Reference Model, internal procedures, and applicable regulatory expectations.
Support inspection and audit preparation, including TMF storyboarding, document retrieval readiness, issue remediation, and response support.
Manage and provide oversight of FSP TMF resources, including workload management, performance expectations, issue resolution, quality review, and escalation of operational risks.
Establish and maintain consistent TMF QC oversight processes, including sponsor QC review, sampling strategy, quality issue tracking, and remediation follow-up.
Partner with Clinical Operations, Study Teams, Quality, Regulatory, Clinical Systems, and vendors to ensure TMF expectations are understood and consistently executed.
Monitor TMF health, completeness, timeliness, quality, and inspection readiness metrics; identify trends, risks, and areas requiring corrective action.
Lead TMF issue management and escalation, ensuring gaps, overdue records, quality findings, and systemic risks are documented, assigned, tracked, and resolved.
Drive consistent adoption of TMF processes, tools, templates, naming conventions, metadata expectations, and quality standards.
Partner with the Clinical Capabilities Innovation Lead to ensure AI-enabled TMF workflows are operationally sound, compliant, and supported by appropriate human oversight.
Identify continuous improvement opportunities across TMF operations, QC, metrics, governance, vendor oversight, and inspection readiness.