Associate Director, Clinical Capabilities Innovation

Madrigal Pharmaceuticals; Waltham (MA); On-site; USD 172,000 - 210,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

401(k)

Job summary

Madrigal Pharmaceuticals is seeking a Clinical Capabilities Innovation Lead to design and launch AI-enabled clinical operations capabilities, starting with eTMF. You will partner with Clinical Operations, TMF Operations, Quality, and IT to deliver scalable, compliant solutions that improve efficiency and inspection readiness.

The role requires deep experience in clinical systems, especially Veeva Vault, and a strong track record translating business needs into technical designs with governance

Qualifications

• Bachelor’s degree in life sciences, information systems, or related field.
• 10–12 years in clinical operations systems with biotechnology/pharma experience.
• Experience with clinical systems, eTMF operations, or related functions.
• Strong knowledge of GCP, sponsor oversight, and regulatory expectations.

Responsibilities

• Design and implement AI-enabled clinical operations capabilities with focus on eTMF.
• Collaborate with IT, QA, and vendors to ensure compliant, scalable solutions.
• Lead governance, performance monitoring, and continuous improvement.
• Stay informed on emerging AI tech and regulatory expectations.

Skills

AI-enabled ops

Cross-functional teamwork

Regulatory compliance

Veeva Vault experience

Education

Bachelor’s degree

Tools

Veeva Vault

Job description

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 Clinical Capabilities Innovation Lead plays an important role in the continued growth and development of Madrigal’s Research and Development (R&D) Department. This role will help design, launch, and continuously improve AI-enabled clinical operations capabilities, with an initial focus on the eTMF ecosystem. The role partners closely with Clinical Operations, TMF Operations, Quality, IT, system vendors, and AI technology partners to develop practical, compliant, scalable solutions that improve efficiency, quality, oversight, and inspection readiness.

Key Responsibilities

Clinical Capabilities Strategy & Design

• Partner with IT and other internal partners to lead the design and implementation of AI-enabled clinical operations capabilities, including agentic workflows for TMF intake, classification, metadata extraction, ALCOA+ checks, periodic review support, and risk-based oversight.
• Translate clinical operations needs into AI-enabled process designs, user requirements, decision logic, exception pathways, training materials, and adoption support materials.
• Own the clinical business design for AI-enabled operating models, ensuring that human control points, exception handling, auditability, validation expectations, and compliance requirements are built into the process from launch.

Systems Enablement & Lifecycle Support

• Support delivery of new capabilities within Veeva Vault and related clinical systems, including process design, configuration input, integration requirements, testing support, user acceptance, and deployment readiness.
• Lead analysis of Veeva and related system releases approximately three times per year, assessing business impact, identifying enhancement opportunities, and partnering with IT to prioritize, test, and implement relevant functionality.
• Support ongoing monitoring of process performance, quality trends, user adoption, and opportunities for continuous improvement.
• Support governance of AI-enabled clinical processes, including performance monitoring, issue trending, feedback loops, change control inputs, and continuous improvement recommendations.

Innovation & Cross-Functional Partnership

• Stay informed on emerging clinical operations technologies, AI capabilities, Veeva Vault functionality, regulatory expectations, and industry trends that may influence future clinical operating models.
• Build strong cross-functional relationships with Clinical Operations, TMF Operations, Quality, IT, vendors, and senior stakeholders to support effective delivery and adoption of new capabilities.
• Other duties as assigned.

Required & Desired Qualifications

• Bachelor’s degree required; degree in life sciences, health sciences, information systems, business, or related field preferred.
• Minimum of 10-12 years relevant overall experience and 8-10 years of progressive clinical operations systems experience, preferably within biotechnology or pharmaceutical industry settings.
• Experience in clinical operations, clinical systems, eTMF operations, study startup, clinical documentation, or related clinical development functions.
• Strong understanding of clinical trial execution, regulated document management, GCP expectations, and sponsor oversight responsibilities.
• Experience with Veeva Vault Clinical applications strongly preferred.
• Veeva Vault Administrator certification preferred.
• Experience with system integrations, data flows, APIs, automation, workflow design, or AI-enabled business processes strongly preferred.
• Demonstrated ability to translate business needs into system requirements, process designs, and operationally practical solutions.
• Strong analytical, problem-solving, and continuous improvement mindset.
• Ability to work effectively across Clinical Operations, IT, Quality, vendors, and senior stakeholders.
• Comfort operating in an evolving environment where processes, technology, and operating models are being built and refined.

Competencies

• Excellent attention to accuracy and detail.
• Effective written and verbal communication skills.
• Strong clinical operations systems experience.
• Ability to translate business needs into technology-enabled solutions.
• Strong software and computer skills, including Microsoft Office applications and clinical systems.
• Solid analytical and proactive problem-solving skills.
• Strong operational skills and demonstrated ability to meet timelines.
• Ability to learn new technologies with ease.
• A team player with ability to build relationships at all levels.
• Demonstrated self-starter with a high level of commitment.
• Change management and continuous improvement mindset.
• Regulated systems mindset with focus on quality, compliance, and inspection readiness.

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.

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 $172,000 - $210,000 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 [e-mail].

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: 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 [e-mail].