Director, Clinical Operations

Madrigal Pharmaceuticals • Conshohocken, PA

5d • $212,000 - $260,000

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. The Director of Clinical Operations will provide operational leadership for the planning, execution, and oversight of Phase I-IV clinical trials. This role is responsible for end-to-end trial planning and delivery, with a strong emphasis on CRO and vendor management, timeline and budget accountability, and high-quality execution in compliance with global regulatory requirements. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to corporate objectives. The ideal candidate is a hands-on clinical trial leader who thrives in a rapidly growing biotech environment.

Requirements

• Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred
• Minimum of 12-15 years of clinical trial experience.
• Demonstrated experience managing Phase I-IV clinical trials.
• Experience in a rapidly growing biotech or similarly dynamic environment preferred.
• Experience with first-in-human studies is strongly preferred.
• Therapeutic experience in metabolic and / or cardiovascular clinical studies is preferred
• Strong understanding of clinical trial operations and GCP.
• Proven CRO oversight and vendor management capabilities.
• Experience working in core systems such as CTMS; eTMF; EDC; IRT.
• Excellent project management and organizational skills.
• Ability to operate independently while collaborating cross-functionally.
• Strong communication skills and attention to detail.
• Comfortable working in a fast-paced, evolving environment.

Responsibilities

• Lead operational execution of Phase I-IV clinical trials.
• Oversee and manage trial startup, conduct, close-out, and inspection readiness.
• Embrace an ownership mindset assessing, managing and communicating risks or issues associated with delivery of the clinical trial(s).
• Accountable to ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and applicable regional regulations.
• Lead CRO selection, contracting, and ongoing oversight for responsible trials.
• Serve as the primary operational liaison with CROs and key vendors.
• Monitor CRO performance, timelines, deliverables, quality, and budgets.
• Collaborate with CRO and vendors to mitigate operational risks and issues.
• Represent Madrigal during site interactions collaboratively with a focus on patients in mind (i.e., Site Initiation Visits, Investigator Meetings as needed)
• Collaborate with key stakeholders to design, develop and review study-related documents (i.e., site study manuals, project tools, monitoring plans, tracking tools, and informed consent forms).
• Assist with the development and review of regulatory submissions.
• Lead and manage trial level meetings and deliverables.
• Identify and oversee site identification, feasibility, activation, enrollment, and retention strategies.
• Collaborates with data management in the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT.
• Ensure that CRF data queries are resolved in collaboration with data management and CRAs.
• Coordinates and oversees Investigational Product including overall accountability and reconciliation.
• Manages and/or oversees study budget and payment process for all clinical trial vendors including investigative sites.
• Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG) in collaboration with CRO.
• Partners closely with internal partners such as Clinical Development, Regulatory Affairs, Data Management, Project and Portfolio Management, Biostatistics and Data Science, Safety, Quality, and Supply Chain Planning & Operations.
• Provide operational input into protocol development strategy.
• Supports INDs, CTAs, protocol amendments, and other regulatory submissions from an operational perspective.
• Ensures ongoing inspection readiness at the study, site, and vendor levels.
• Supports audits and regulatory inspections.
• Helps to develop, implement, and maintain SOPs and best practices appropriate for a rapidly growing biotech organization.
• Other duties as assigned.

Benefits

• Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
• Full-time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite.
• 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.

What This Job Offers

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