Director, Clinical Operations

Madrigal Pharmaceuticals • Conshohocken, PA

1d • Hybrid

About The Position

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. Madrigal is seeking to become a global biopharmaceutical company and to bring Rezdiffra™ (resmetirom) to patients with nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company is in a critical growth phase and is expanding its Clinical Operations leadership to support late-stage development, global trial execution, and operational readiness for commercialization.

Requirements

• Experience phase 2 / 3 global studies
• Demonstrated ability to scale teams and processes
• Experience overseeing CROs and supporting vendor teams
• Proficient in CTMS, EDC and eTMF systems (e.g. Veeva, Medidata, etc.).
• Strong knowledge of ICH-GCP and EU regulatory environment (e.g. EU CTR, local ethics processes).
• Demonstrated ability to lead CRA teams in a global environment.
• Excellent written and verbal communication skills in English; proficiency in additional European languages is a plus.
• Detail-oriented with strong organizational and project management skills.
• Strong scientific and technical skills
• Ability to lead a high functioning team and delegate
• Strong interpersonal capabilities and ability to build and maintain networks
• Ability to influence both in-line communications and cross-functional teams
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Fluent in English language
• Ability to present clearly using scientific and regulatory terminology
• Excellent organizational skills
• Comfort with ambiguity
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred).
• 10+ years of clinical operations experience, including 5+ years in a leadership role managing complex global trials.

Nice To Haves

• MASH / MASH parallel therapeutic expertise (preferred).

Responsibilities

• Clinical Trial Oversight Lead end-to-end planning and operational execution of assigned clinical studies in accordance with GCP, regulatory requirements, and company SOPs
• Oversee study timelines, budgets, enrollment progress, and key milestones, ensuring proactive risk mitigation and issue resolution
• Serve as the primary point of contact for clinical trial managers, CROs, and key site networks
• Team Leadership and Cross-functional Collaboration Manage and mentor Clinical Trial Managers, Clinical Research Associates (CRAs), and supporting operations staff
• Foster a culture of accountability, excellence, and continuous improvement
• Contribute to organizational growth by refining clinical processes, tools, and SOPs
• Contribute to the development of meeting materials and content and participate in Departmental meetings
• Vendor and CRO Management Select, negotiate with, and manage CROs, central labs, and other third-party vendors
• Ensure high standards of vendor performance through KPIs, quality metrics, and governance structures
• Support implementation of vendor oversight frameworks and risk-based monitoring strategies
• Budget & Resource Management Develop and track clinical budgets and team resource allocations
• Provide regular reports and forecasting to senior management and Executive Directors showcasing progress, risks and mitigation strategies
• Quality, Compliance & Inspection Readiness Ensure that all clinical operations activities are conducted in accordance with ICH-GCP, regulatory guidelines and internal SOPs
• Support inspection readiness and participate in audits or health authority inspections, always ensuring inspection readiness

Benefits

• equity
• flexible paid time off
• medical
• dental
• vision and life/disability insurance
• 401(k) offerings (i.e., traditional, Roth, and employer match)
• supplemental life insurance
• legal services
• mental health benefits through our Employee Assistance Program for employees and their family

What This Job Offers

• Job Type: Full-time
• Career Level: Director