Associate Director, Clinical Capabilities Innovation

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

Benefits offered by this job

Equity

Bonus

401(k) plan

Medical, dental, vision

Paid time off

Mental health benefits

Job summary

Madrigal is seeking a Clinical Capabilities Innovation Lead to design, launch, and optimize AI-enabled clinical operations capabilities, focusing on the eTMF ecosystem. You will collaborate with Clinical Operations, TMF Operations, Quality, and IT to deliver scalable, compliant solutions and drive efficiency.

You will lead system design for AI-enabled operating models, support Veeva Vault configurations and releases, and ensure inspection readiness with a strong emphasis on data integrity and

Qualifications

• Bachelor’s degree required; life sciences, health sciences, information systems, or related field preferred.
• 10–12 years total experience and 8–10 years in progressive clinical operations systems roles in biotech/pharma.
• Experience in clinical operations, clinical systems, eTMF operations, or related clinical development functions.
• Veeva Vault Administrator certification preferred.
• Experience with system integrations, data flows, APIs, automation, and AI-enabled processes.
• Ability to translate business needs into system requirements and practical solutions.
• Strong analytical, problem-solving, and stakeholder management skills.

Responsibilities

• Design and implement AI-enabled clinical operations capabilities within eTMF and related systems.
• Partner with IT, QA, and vendors to ensure compliance, validation, and inspection readiness.
• Lead lifecycle support for Veeva Vault deployments and system releases.
• Analyze system updates and prioritize enhancements with IT teams.
• Monitor process performance, quality trends, and user adoption for continuous improvement.
• Build cross-functional relationships with Clinical Operations, IT, and Quality.

Skills

Clinical operations systems

Veeva Vault Clinical applications

APIs and data integrations

AI-enabled process design

Quality and regulatory compliance

Education

Bachelor's degree in life sciences, health sciences, information systems, or related field

Tools

Veeva Vault

APIs

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.

Clinical Capabilities Innovation Lead

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.

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.

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.

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.