Associate Director, Trial Master File Operations
Madrigal Pharmaceuticals
Summary
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.
Job description
Summary of Job Highlight
- 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
Key Responsibilities
TMF Operations & Inspection Readiness
- 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.
FSP, Vendor & Sponsor Oversight
- 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.
Metrics, Risk Management & Continuous Improvement
- 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.
Required & Desired Qualifications
- 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.
Competencies
- TMF operations leadership
- Inspection readiness
- Sponsor oversight
- FSP and vendor management
- QC and quality issue management
- Metrics and governance
- Risk-based TMF review
- Clinical documentation standards
- Cross-functional communication
- Operational discipline
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.
Benefits
- Base pay
- Bonus
- Equity
- Flexible paid time off
- Medical, Dental & Vision
- Life/Disability Insurance
- 401(k) Matching
- Supplemental life insurance
- Legal services
- Mental health benefits
- Employee Assistance Program
Company overview
Madrigal Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), a serious form of fatty liver disease. The company's lead product, Rezdiffra (resmetirom), is a once-daily, oral thyroid hormone receptor (THR)-β selective agonist that targets key underlying causes of MASH in the liver. Rezdiffra received FDA approval in 2024 as the first treatment for MASH with moderate to advanced liver fibrosis, representing a significant breakthrough in hepatology. Headquartered in Conshohocken, Pennsylvania, Madrigal is publicly traded on NASDAQ under the symbol MDGL. The company continues to advance its clinical development programs, including ongoing Phase 3 trials evaluating Rezdiffra for the treatment of compensated MASH cirrhosis. Madrigal's innovative approach addresses a critical unmet medical need in liver disease therapeutics.