Associate Director, Clinical Capabilities Innovation
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals seeks an Associate Director to lead the design and implementation of AI-enabled clinical operations capabilities, particularly within the electronic Trial Master File ecosystem. The role partners across clinical operations, IT, quality, and vendors to develop compliant, scalable solutions that enhance efficiency and inspection readiness.
Responsibilities
- Lead design and implementation of AI-enabled clinical operations capabilities including eTMF workflows, metadata extraction, and risk-based oversight
- Translate clinical operations needs into process designs, user requirements, and compliance frameworks with human control points built in
- Support delivery of new capabilities within Veeva Vault, including process design, configuration, integration, testing, and deployment readiness
- Monitor system performance, quality trends, and user adoption; recommend continuous improvements and governance inputs
- Build cross-functional partnerships with Clinical Operations, TMF, Quality, IT, and vendors to enable effective capability delivery and adoption
Requirements
- Bachelor's degree in life sciences, health sciences, information systems, business, or related field
- 10–12 years overall relevant experience plus 8–10 years progressive clinical operations systems experience
- Experience with clinical operations, eTMF, study startup, or clinical development functions
- Strong understanding of clinical trial execution, regulated document management, and GCP expectations
- Veeva Vault Clinical applications experience; Vault Administrator certification preferred
- Experience with system integrations, APIs, automation, workflow design, or AI-enabled processes
- Demonstrated ability to translate business needs into system requirements and operationally practical solutions
Vacancy posted 5 days ago
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