Director, Clinical Operations

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Title: Director, Clinical Operations

 Department: Research and Development
 Location: Hybrid, 3 days a week in Conshohocken office
 

About Madrigal:

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra™ (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

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.

Position Responsibilities:

The Director of Clinical Operations will lead the planning, execution, and delivery of global clinical trials across all phases of development. This individual will manage clinical trial teams and external vendors across multiple functions to ensure timely, high-quality, and compliant execution of clinical programs. The Director will provide leadership in cross-functional collaboration, resourcing, budget oversight, and strategic trial planning aligned with corporate objectives. This role is both strategic and operational and requires hands-on leadership.

The ideal candidate brings deep clinical trial management expertise, operational excellence, and strong leadership capabilities

Key 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

Experience and Professional Qualifications:

The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company:

• Experience phase 2 / 3 global studies
• Demonstrated ability to scale teams and processes
• Experience overseeing CROs and supporting vendor teams
• MASH / MASH parallel therapeutic expertise (preferred).
• Proficient in CTMS, EDC and eTMF systems (e.g. Veeva, Medidata, etc.).
• Strong knowledge of ICH-GCP and EU regulatory environment (e.g. EU CT