Director, Clinical Operations

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.

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 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.

Critical Competencies For Success

The ideal candidate displays the following professional competencies:

• 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

Education & Experience

• 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.

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 $212,000 - $260,000 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.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [email protected].

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to [email protected] .