Associate Director, Clinical Site Management and Monitoring Oversight

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.

This role will partner with the Sr Director to develop the Clinical Monitoring Oversight program, and to build and manage an internal US CRA (Monitoring) field force. The Associate Director role collaborates with CRO partners and cross-functional study teams to drive monitoring and operational excellence at the CRA and site levels by performing targeted, risk-based oversight activities. This role also engages Madrigal sites and networks to develop relationships and support optimal site performance within Madrigal trials.

The Associate Director will also manage an internal CRA field team within their region of the US.

• Monitoring Oversight Partner with the Sr Director of CRA Field Force to develop and implement the Madrigal Monitoring Oversight program to ensure sponsor oversight of outsourced trials
• Utilizing a risk-based approach, perform remote and on-site Monitoring Oversight Visits within a regional, US territory
• Document and communicate visit findings to CRO partners and Madrigal stakeholders; assess trends across studies and sites; and manage mitigations, resolutions and CAPAs to remediate identified issues as needed
• Provide sponsor support to CRAs and sites at Site Qualification Visits, Site Initiation Visits, and Monitoring Visits
• Develop and foster relationships with Madrigal sites to drive compliance and support optimal performance
• Serve as a Madrigal escalation resource and partner with the CRO, trial team and/or sites to resolve compliance, data and/or monitoring issues

• Partner with the Sr Director of CRA Field Force to develop and implement the internal Madrigal Monitoring program
• Build and manage a group of high-performing Madrigal CRAs that monitor Madrigal trials and perform oversight of monitoring on outsourced trials
• Contribute to the creation of controlled documents (SOPs, Work Instructions, Job Aids, Templates, Forms) pertaining to Monitoring, and customize for insourced trials
• Develop interview, onboarding, and continuous education training materials for Madrigal CRAs
• Strategically allocate internal CRA resources to studies and sites
• Review and approve Madrigal CRA Monitoring Visit schedules, reports and expenses
• Perform Monitoring Oversight Visits to assess and manage internal CRA performance; train and support CRAs to perform Oversight Visits in outsourced trials
• Support internal CRAs and engage with sites at Site Qualification Visits and Site Initiation Visits
• Develop internal site and monitoring analytics and dashboards to assess site health and monitoring performance
• Customize trial Clinical Site Monitoring Plan for studies monitored by Madrigal
• Collaborate with cross-functional stakeholders at Madrigal to ensure trial milestones and goals are met; represent the CRA Field Force team at trial team meetings to share metrics, trends and issues pertaining to sites and monitoring
• Conduct site network, site and KOL engagement activities on behalf of Madrigal within a regional US territory

• The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company
• Proven track record of successfully managing CRAs across various phases and therapeutic areas
• Experience with developing training programs, systems and tools for CRAs
• Demonstrated ability to influence peers within a matrixed and fast-paced organization
• Strong strategic thinking, problem-solving, and influencing skills
• Recent experience with Veeva Vault systems (TMF, CTMS)

• Strong interpersonal capabilities; demonstrates an ability to build and maintain positive site and CRA relationships
• Strong verbal communication and technical writing skills
• Fluent in English language
• Ability to present concepts clearly utilizing scientific and regulatory…