Associate Director, AI-Enabled Clinical Ops

Madrigal Pharmaceuticals; Conshohocken (Montgomery County); On-site; USD 172,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Comprehensive benefits

Job summary

Madrigal Pharmaceuticals is seeking a Clinical Capabilities Innovation Lead to advance AI-enabled clinical operations, with an initial focus on the eTMF ecosystem. The role partners 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.

The ideal candidate has 10–12 years in clinical operations systems, experience with Veeva Vault,

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.
• 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.

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 human control points, exception handling, auditability, validation expectations, and compliance requirements are built into the process from launch.

Skills

Analytical skills

Problem-solving

Continuous improvement mindset

Cross-functional collaboration

Change management

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva Vault

APIs & system integrations

Job description

Madrigal Pharmaceuticals is seeking a Clinical Capabilities Innovation Lead to advance AI-enabled clinical operations, with an initial focus on the eTMF ecosystem. The role partners 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.

The ideal candidate has 10–12 years in clinical operations systems, experience with Veeva Vault,