Associate Director, Clinical Trial Lead (Princeton, NJ/ South San Francisco)

Kardigan is seeking an Associate Director, Clinical Trial Lead to manage one of its cardiovascular clinical studies. As a Clinical Trial Lead (CTL), you will be part of the Clinical Operations team reporting to the asset’s Clinical Operations Program Leader (COPL).

Requirements

• Minimum of BA/BS with approximately 10+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs
• Experience within the field of cardiovascular studies and/or rare disease is desirable
• Experience in early and late phase drug development; late-stage (Phase 2/3) development experience is required
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Excellent communication skills, both verbal and written
• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence
• Confidence to challenge status-quo thinking and behavior
• Can work with agility and an innovative mindset
• Experience in ICH/GCP inspections, audits and inspection preparedness
• Experience in mentoring Clinical Operations staff

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Tuition Reimbursement
• Relocation Assistance