Associate Director, Clinical Operations

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 of Clinical Operations supports the operational planning, execution, and oversight of Phase I–IV clinical trials. This role is responsible for day-to-day operational management of assigned studies, with a strong focus on CRO and vendor oversight, timelines, budgets, and high-quality execution in compliance with global regulatory requirements. Working closely with the Director and cross-functional partners, the Associate Director contributes to trial strategy, proactively manages risks, and ensures delivery against program and corporate objectives. The ideal candidate is a hands-on clinical operations professional who thrives in a fast-paced, growing biotech environment.

Key Responsibilities

· Support and manage the operational execution of Phase I–IV clinical trials.

· Oversee day-to-day trial activities including startup, conduct, close-out, and inspection readiness for assigned studies.

· Proactively assess, manage, and communicate operational risks and issues related to clinical trial delivery.

· Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and applicable regional regulations.

· Support CRO selection, contracting, and ongoing oversight for assigned trials.

· May serve as a key operational point of contact with CROs and vendors.

· Monitor CRO performance, timelines, deliverables, quality, and budgets, escalating issues as appropriate.

· Collaborate with CROs and vendors to resolve operational challenges and mitigate risks.

· Represent Madrigal during site interactions (e.g., SIVs, investigator meetings) as needed, with a patient-focused mindset.

· Contribute to the development, review, and maintenance of study-related documents (e.g., study manuals, monitoring plans, tracking tools, informed consent forms).

· Support the preparation and review of regulatory submissions.

· Coordinate and support trial-level meetings and deliverables.

· Assist with site identification, feasibility, activation, enrollment, and retention strategies.

· Collaborate with Data Management on CRF design, study tools, EDC/IVRS specifications, and UAT activities.

· Ensure timely resolution of CRF data queries in collaboration with CRAs and Data Management.

· Coordinate and oversee Investigational Product logistics, accountability, and reconciliation.

· Support management of study budgets and site/vendor payment processes.

· Assist in managing clinical trial vendors (e.g., IVRS, central labs, IRBs, central ECG) in collaboration with the CRO.

· Partner closely with internal stakeholders including Clinical Development, Regulatory Affairs, Data Management, Project & Portfolio Management, Biostatistics, Safety, Quality, and Supply Chain.

· Provide operational input into protocol development and amendments.

· Support INDs, CTAs, and other regulatory submissions from an operational perspective.

· Support audit and inspection activities and maintain inspection readiness.

· Contribute to the development and continuous improvement of SOPs, processes, and best practices.

· Other duties as assigned.

Required & Desired Qualifications

· Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.

· Minimum of 10-12 years of clinical trial experience.

· Experience supporting or managing Phase I–IV clinical trials.

· Experience working with CROs and external vendors.

· Experience in a rapidly growing biotech or similar dynamic environment preferred.

· Experience with first-in-human studies preferred.

· Therapeutic experience