Associate Director, Clinical Capabilities Innovation

Madrigal Pharmaceuticals•Waltham, MA

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 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.

Requirements

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.
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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
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.