Associate Director, Trial Master File Operations

Madrigal Pharmaceuticals; Conshohocken (Montgomery County); In loco; USD 179.000 - 206.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity

Comprehensive benefits package

401(k) plan

Descrizione del lavoro

Madrigal Pharmaceuticals is seeking an Associate Director of TMF Operations to lead day-to-day TMF strategy, oversight, and inspection readiness across studies. You will manage FSP resources, ensure QA oversight, and drive metrics-driven governance with cross-functional teams.

The role requires strong TMF expertise, vendor oversight capability, and experience with eTMF systems, ideally Veeva Vault. Competitive salary and equity accompany comprehensive benefits.

Competenze

• Bachelor’s degree required in life sciences, health sciences, clinical research, or related field.
• 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 (Veeva Vault) 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 readiness experience preferred.

Mansioni

• Lead TMF operations across assigned studies, programs, or enterprise TMF model to ensure complete, accurate, timely, inspection-ready documentation.
• Oversee FSP TMF resources, workload management, performance, issue resolution, quality review, and risk escalation.
• Establish and maintain TMF QC oversight processes, sponsor QC review, sampling strategy, quality issue tracking, and remediation follow-up.
• Monitor TMF health, timeliness, quality, and inspection readiness metrics to identify trends and corrective actions.
• Partner with cross-functional teams to ensure TMF expectations are understood and executed.
• Drive continuous improvement in TMF processes, governance, and vendor oversight.
• Support AI-enabled TMF workflows with appropriate human oversight.

Conoscenze

TMF operations leadership

Inspection readiness

Sponsor oversight

FSP & vendor management

Quality issue management

Metrics & governance

Risk-based TMF review

Clinical documentation standards

Cross-functional communication

Operational discipline

Formazione

Bachelor’s degree in life sciences/related field

Strumenti

Veeva Vault eTMF

Descrizione del lavoro

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.
• 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.