Clinical Capabilities Innovation Lead (AI-Driven)

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 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