Associate Director, Clinical Operations - Remote

Overview

The Associate Director, Clinical Operations is a senior leader responsible for overseeing cross-functional clinical teams to achieve key milestones and deliverables while ensuring operational feasibility, adherence to budgets, and timelines.

In Short

• Collaborate with Clinical Operations Program Leads and cross-functional teams to develop and implement study strategies aligned with corporate objectives.
• Manage operational aspects of clinical trials from study planning through closeout, ensuring adherence to timelines, budgets, and regulatory standards.
• Partner with leadership to optimize resource allocation and ensure alignment with corporate priorities.
• Oversee the execution of clinical studies, including investigator selection, study startup, recruitment, data collection, and closeout.
• Act as the clinical operations lead in cross-functional study teams, ensuring alignment and efficient communication among stakeholders.
• Monitor CROs, vendors, and site performance, ensuring quality deliverables and compliance with ICH-GCP and regulatory guidelines.
• Provide operational input into clinical study documents such as protocols, informed consent forms, and operational manuals.
• Contribute to vendor selection and contract negotiations, ensuring alignment with study requirements.
• Define key deliverables and performance metrics for vendors and CROs, regularly assessing performance to ensure accountability.
• Address and resolve operational challenges in collaboration with internal and external partners.

Requirements

• Bachelor’s degree required, advanced degree preferred.
• Minimum of 8–10 years of experience in Clinical Operations, with at least 3 years in a leadership role.
• Strong experience in managing complex Phase 2/3 clinical trials, including rare disease or neuromuscular studies.
• Proven expertise in global trial management, CRO oversight, and vendor negotiations.
• Comprehensive knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Strong leadership skills with the ability to mentor and inspire team members.
• Exceptional organizational and problem-solving skills with a focus on risk management.
• Excellent communication skills, both written and oral, with the ability to collaborate across diverse teams.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.
• Demonstrates initiative, attention to detail, and the ability to adapt to change.

Benefits

• The base salary range for this role is $180,500 - $199,500.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match.
• The comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.