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.

Key Responsibilities:

• 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

• CRA Field Force Team Development and Management

• 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

Experience and Professional Qualifications:

• 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)

• Critical Competencies for Success:
  • 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 terminology
  • Sound organizational skills that support the ability to work independently and efficiently
  • Proactive approach to identifying challenges and solutions
  • Detail-oriented nature paired with critical reasoning skills to identify and resolve issues

Required & Desired Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus
• 10+ years of clinical operations or monitoring experience, with a minimum of 2+ years in a field CRA role, and additional 2+ years in a prior CRA Manager or Monitoring Oversight (of outsourced monitoring) role
• Ability to travel within a regional, US territory up to 50% (may be lower depending on business need)
• Located within a one hour drive of an airport

#LIRemote

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing 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.

All employees receive equity, which we believe reinforces our ownership culture. 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 $172,000 - $211,000 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.