Associate Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the operational delivery for one or more Dry AMD clinical trials from the initiation phase to the closure.

• Lead study timelines, ensure quality, and resolve issues as they arise.

• Supervise operational plans at the study level and develop risk mitigation strategies.

• Contribute to and assist with NDAs, MAAs, inspection readiness efforts, and regulatory inspections.

• Act as a subject matter expert during regulatory inspections.

• Identify and choose vendors, review contracts and work orders critically, and manage vendor performance and relationships.

• Oversee CRO monitoring activities to guarantee that site performance, enrollment, and data quality align with study objectives.

• Assist in the development and monitoring of study and program budgets.

• Highlight budget discrepancies and ensure fiscal responsibility.

• Create and enhance SOPs, systems, and workflows to facilitate scalable clinical operations.

• Ensure that trials adhere to GCP and relevant regulatory standards.

• Maintain inspection-ready trial master files and clinical systems.

• Collaborate with internal cross-functional teams to ensure operational plans align with program strategy.

• Provide timely updates regarding study status, risks, and timelines to program and senior leadership.

• Contribute to shaping Development Operations processes and organizational structure.

• Build and lead a team as the function expands.

⛳️ Requirements

• A Bachelor’s degree is required; a Master’s degree is preferred.

• 5–7+ years of experience in Clinical Operations across various trial phases.

• 2+ years of experience in ophthalmology; experience with retina is a plus.

• Extensive experience in managing CROs, vendors, and clinical sites.

• Strong knowledge of GCP, ICH guidelines, and clinical trial regulations.

• Demonstrated ability to shape operational strategy and drive execution across multiple studies or programs simultaneously.

• Excellent budget and vendor management capabilities.

• Experience in tracking expenditures and identifying variances.

• Strong collaboration skills across functions.

• Ability to effectively partner with internal and external stakeholders.

• Comfortable operating independently in a fast-paced and lean biotech environment.

• High integrity and sound judgment.

• Proven track record of delivering complex clinical trials on time and within budget.

• Applicants must have authorization to work in the United States.

🏝️ Benefits

• Equity

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k)

• Accrued paid time off policy

• Competitive salary

• Strong equity incentives

• Commitment to diversity, equity, and inclusion