Sr. Manager, Clinical Trial Lead

The role

The Sr. Manager, Clinical Trial Lead will manage cardiovascular clinical studies. This regional role ensures project deliverables meet budget, timelines, and quality standards.

What you will do

• Lead the planning, execution, and delivery of assigned clinical trials.
• Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report.
• Serve as the primary operational point of contact for the cross-functional study team.
• Align team execution with the study’s regulatory submission strategy and overall development plan.
• Oversee site feasibility, selection, initiation, and activation.
• Partner with CTMs to ensure vendor and site readiness.
• Develop and execute participant recruitment strategies.
• Lead operational strategy related to drug supply, remote monitoring, and decentralized trial processes.
• Collaborate with the Clinical Development Lead on protocol development, amendments, and master ICFs.
• Direct and manage CRO and vendor partnerships.

Required qualifications

• Minimum of BA/BS
• Approximately 8+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs
• Some late-stage development experience is required
• Multi-dimensional Clinical Operations background
• Excellent communication skills, both verbal and written
• Demonstrated ability to lead & collaborate with cross-functional teams
• Experience in ICH/GCP inspections, audits and inspection preparedness
• Experience in mentoring Clinical Operations staff

Nice to have

• Advanced degree
• Experience within the field of cardiovascular studies and/or rare disease is desirable

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. The co-founders previously led MyoKardia to discover and develop mavacamten.