Associate Director, Trial Master File Operations

Regulatory Jobs; Conshohocken (Montgomery County); On-site; USD 179,000 - 206,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

401(k)

Job summary

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Associate Director TMF Operations will lead day-to-day TMF operational strategy, oversight, and inspector readiness across studies, ensuring documentation is complete, timely, and compliant with regulatory expectations.

This role manages FSP resources, drives quality, and partners with Clinical Operations, Quality, Regulatory, and vendors.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years in TMF/eTMF operations or clinical documentation.
• Experience overseeing FSP/CRO/vendor TMF activities.
• Strong knowledge of GCP, inspection readiness, sponsor oversight.
• Experience with eTMF systems; Veeva Vault preferred.
• Familiarity with CDISC TMF Reference Model.
• Experience developing TMF metrics and governance materials.
• Strong organizational and stakeholder management skills.
• Ability to manage competing priorities across studies.
• Inspection or health authority readiness experience.

Responsibilities

• Lead TMF operations to ensure complete, accurate, timely, and inspection-ready documentation.
• Oversee FSP TMF resources, performance, issue resolution, and risk escalation.
• Maintain TMF QC processes, sponsor QC review, sampling, and remediation follow-up.
• Monitor TMF health, metrics, and trends; drive corrective actions.
• Collaborate with Clinical Ops, Study Teams, Quality, Regulatory, and vendors.
• Support AI-enabled TMF workflows with appropriate human oversight.
• Identify continuous improvement opportunities across TMF operations and governance.

Skills

TMF operations

eTMF oversight

GCP knowledge

Vendor management

FSP/CRO oversight

Veeva Vault eTMF

CDISC TMF Reference Model

Regulatory compliance

Stakeholder management

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva Vault eTMF

Job description

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.

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.
• Minimum of 10+ years of relevant experience; 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

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. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs, and market demands.

As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $179,364 - $205,678 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.