New · posted Oct 31
Madrigal Pharmaceuticals · Pharmaceuticals
Associate Director, Trial Master File Operations
- Conshohocken, PA +1 more
- On-site
- Full-time
- Director
The role
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
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.
What you need
Required & Desired Qualificationsnice to have
• 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.
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.
Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.
Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [email protected].
What you'll do
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
• 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.
Pay and benefits
$179,364 – $205,678 a year
Employer providedAs 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.
Base salary, bonus and equity
Flexible paid time off
Medical, dental, vision and life/disability insurance
401(k) with employer match
Employee Assistance Program mental health benefits
Voluntary benefits (supplemental life, legal services)
Where you'll work
Conshohocken, PA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Waltham, MA
More jobs in Conshohocken, PA +1 moreEqual opportunity, accessibility and legal noticesMadrigal Pharmaceuticals's statements, word for word
We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [email protected].
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Clinical Operations roles at this level.
This roleEmployer provided
Director roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $179,364 | — | $205,678 |
| All US (middle half) | $216,250 | $233,000 | $244,000 |
This role: Madrigal Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 42 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Madrigal's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 45 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct24
- GMP and compliance13
- Collaboration and leadership13
- Documentation and SOPs9
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Madrigal on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 3
- Locations
By discipline
- Clinical7 58%
- Quality3 25%
- Regulatory2 17%
By level
- Director10 83%
- VP & Executive1 8%
- Manager1 8%
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Associate Director, Trial Master File Operations at Madrigal
Open until filled. $179K–$206K a year, employer provided.