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
Vacancy posted 23 days ago
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