Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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).

Senior Director, US CRA Field Force Head

Department: Research and Development
Location: Hybrid, 3 days a week in Conshohocken office
Reports to: SVP Clinical Management

Position Responsibilities:

This role will be responsible for developing, leading, and optimizing the US CRA field force to ensure successful clinical study execution. This role provides strategic direction, operational oversight, and leadership to a large, geographically dispersed team of CRAs and field managers. The Senior Director partners with CROs and cross-functional teams to drive operational excellence, ensure compliance with regulatory requirements, and deliver high-quality clinical data on-time and on-budget.

Key Responsibilities

Strategic Leadership

• Develop and execute the US CRA field strategy aligned to organizational goals, standards, and clinical development plans
• Lead change management initiatives to drive continuous improvement and operational efficiency
• Serve as a key member of the Global Field Operations leadership team by contributing to overall strategy and decision-making
• Partner with international colleagues to create and drive a cohesive global CRA field force and management strategy

Team Management & Development

• Manage field managers and oversees the performance of the full US CRA team
• Recruit and trains top talent, fostering a culture of high performance, accountability, and professional growth
• Provide coaching, mentoring, and career development opportunities for direct reports
• Develop level appropriate training for teams and develops mentors within the US CRA team

Monitoring & Resource Allocation

• Maintain ability to lead study monitoring efforts
• Develop resource allocation model for regional and national CRA team
• Monitor, in a limited capacity, when indicated based on study-specific timelines and deliverables

Operational Excellence

• Oversee resource allocation, workload balancing, and territory management to maximize productivity and trial performance
• Monitor KPIs and implement corrective actions to meet and exceed operational targets
• Oversee monitoring to ensure compliance with SOPs, GCP, and all applicable regulatory requirements

Collaboration & Stakeholder Management

• Partner with Clinical Operations, Data Management, Quality, and other functions to drive seamless clinical study execution
• Serve as the primary escalation point for field-related issues and proactively work to resolve challenges
• Represent the US CRA field force in cross-functional meetings and external engagements

Process Improvement & Innovation

• Review, develop and revise Standard Operating Procedures and Working Practice documents and forms to ensure compliance with ICH/GCP and other applicable local and regulatory requirements.
• Identify and implement best practices, process enhancements, and innovative solutions to improve field force effectiveness
• Leverage technology and data analytics to drive informed decision-making and operational transparency

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 leading CRA teams across various phases and types of studies
• Strong knowledge of regulatory expectations related to post-marketing commitments, risk management, and lifecycle evidence generation
• Experience in developing training programs for CRA colleagues
• Demonstrated ability to lead within a matrixed and fast-paced organization
• Excellent strategic thinking, problem-solving, and influencing skills
• Familiarity with FD, EMA, PMDA and other regulatory body interactions
• Experience in multiple therapeutic areas, particularly in MASH or other liver-related indications

Critical Competencies for Success:

The ideal candidate displays the following professional competencies:

• Strong scientific and technical skills
• Strong interpersonal capabilities and ability to build and maintain networks
• 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
• Sound organizational skills
• Comfort with ambiguity
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Project management skills and focus on delivery of results
• Ability to develop a high functioning team and effectively delegate
• Ability to deliver executive briefings and board-level updates

Education & Experience:

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree a plus
• 15+ years of clinical operations or clinical development experience, with a minimum of 10+ years in a operational leadership role

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

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.

Please be aware that we are currently receiving numerous 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. Interviews with Madrigal are conducted via the Zoom platform.

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 Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.