Executive Director, Operations Lead

Madrigal Pharmaceuticals

Madrigal Pharmaceuticals seeks an Executive Director of Operations to lead clinical trial management and oversee a clinical operations team across the product development lifecycle. The role requires strategic oversight of study planning, execution, regulatory compliance, and cross-functional collaboration to support the company's MASH treatment programs.

Responsibilities

Manage clinical trial processes from planning through implementation to final closeout
Lead and mentor clinical operations team; establish performance indicators and quality standards
Oversee CRO selection, budget negotiation, and investigator grant proposals
Ensure compliance with company SOPs, regulatory guidelines, and patient safety standards
Coordinate with biometrics, regulatory, and clinical teams on data deliverables and submissions

Requirements

Bachelor's degree in life sciences, nursing, or pharmacy; advanced degree preferred
Minimum 10 years of clinical operations experience in study development and execution
Expertise across clinical trial lifecycle from planning through database locking and regulatory inspection
Experience with pivotal, multi-site, multi-national trials and NDA/IND development
Track record collaborating with cross-functional teams to deliver on time and budget
Knowledge of ICH-GCP guidelines, regulatory processes, and global drug development

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Vacancy posted 22 days ago

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