Sr. Manager, Clinical Trial Lead

About the Company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Led by industry veterans, the company utilizes a cutting-edge discovery and translational research platform to develop targeted treatments for cardiovascular diseases.

Responsibilities

• Lead the planning, execution, and delivery of assigned regional clinical trials
• Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report
• Oversee site feasibility, selection, initiation, and activation
• Direct and manage CRO and vendor partnerships, ensuring accountability for timelines, quality, and budget
• Ensure compliance with ICH-GCP, local regulations, and company SOPs
• Manage protocol deviations and implement CAPAs when required
• Provide coaching, feedback, and performance management to direct reports including CTAs and CTMs

Requirements

• BA/BS degree with approximately 8+ years of experience in global clinical trial management
• Experience in pharmaceutical companies and/or CROs
• Experience in early and late phase drug development (late-stage required)
• Multi-dimensional Clinical Operations background
• Experience in ICH/GCP inspections, audits, and inspection preparedness
• Excellent verbal and written communication skills

Preferred Qualifications

• Advanced degree
• Experience within the field of cardiovascular studies or rare disease
• Experience in mentoring Clinical Operations staff