Director, Clinical Operations (Unblinded) - Remote

Overview

The Director, Clinical Operations (Unblinded) is a senior leader responsible for overseeing unblinded activities across multiple clinical studies within Avidity’s programs. This role provides strategic leadership, mentorship, and operational oversight to drive excellence in clinical trial execution while ensuring compliance with GCP and regulatory guidelines.

In Short

• Lead the unblinded Clinical Operations team in planning and execution of clinical studies.
• Oversee study execution in collaboration with CROs and vendors.
• Provide oversight of study CROs and vendors.
• Develop and review clinical trial documents.
• Serve as an escalation point for unblinded study team members.
• Ensure compliance and maintenance of an inspection-ready Unblinded Trial Master File.
• Collaborate on study-specific training for study teams and sites.
• Conduct co-monitoring visits with unblinded CRAs.
• Facilitate unblinded Sponsor oversight visits.
• Support planning and forecasting for study protocols.

Requirements

• Bachelor’s Degree required; Advanced Degree preferred.
• Minimum of 12 years of experience in Clinical Operations.
• Extensive knowledge of clinical trial design and regulatory requirements.
• Experience in developing study budgets and managing timelines.
• Proven track record of managing unblinded study tasks and teams.
• Strong background in vendor selection and oversight.
• Technical proficiency with clinical systems.
• Experience in managing complex rare disease clinical trials.
• Excellent communication and organizational skills.
• Willingness to travel globally as required.

Benefits

• Base salary range of $218,500 - $241,500.
• Competitive compensation and benefits including bonuses and stock options.
• Comprehensive wellness program including medical, dental, and vision coverage.
• 401(k) with employer match.
• Commitment to learning and development opportunities.