Associate Director Clinical Operations - Retina

Job Title: Associate Director Clinical Operations

Location: San Francisco (Hybrid 1-3 days a week Onsite)

Reports To: Executive Director, Clinical Operations

Overview

We are seeking a strategic and execution-focused Associate Direcctor of Clinical Operations with deep experience in ophthalmology to support the design and delivery of clinical programs. This individual will support the end to end operational execution of clinical trials across retinal and anterior segment indications, ensuring high quality, efficient study conduct in alignment with regulatory expectations.

This role requires a leader who understands the unique complexities of ophthalmic trials, including specialized endpoints, imaging modalities, site dynamics, and patient recruitment challenges.

Key Responsibilities

Clinical Operations Leadership

• Provide strategic leadership for all clinical operations activities across ophthalmology programs (Experience in Retina is highly desired)
• Build, lead, and mentor a high performing clinical operations team, including Clinical Trial Managers, CRAs, and in-house staff
• Develop and scale infrastructure, SOPs, and operational frameworks tailored to ophthalmic trials
• Collaborate cross functionally with Clinical Development, Regulatory, Biostatistics, Data Management, and Medical Affairs

Trial Execution and Delivery

• Oversee planning, startup, execution, and closeout of global ophthalmology trials across Phase I through Phase III
• Ensure delivery against timelines, budgets, and quality standards
• Manage study risks specific to ophthalmology, including enrollment challenges, variability in visual acuity endpoints, and imaging consistency
• Drive site selection strategies focused on high enrolling ophthalmology centers and key opinion leader networks

Ophthalmology-Specific Expertise

• Oversee implementation and standardization of ophthalmic endpoints such as BCVA, OCT imaging, visual field testing, and intraocular pressure measurements
• Ensure proper vendor selection and oversight for central reading centers, imaging vendors, and specialized ophthalmic CRO capabilities
• Maintain consistency and quality in imaging data acquisition and grading across sites
• Guide protocol development with a strong understanding of ophthalmology trial design and patient pathways

Vendor and CRO Oversight

• Lead selection, contracting, and oversight of CROs, central labs, imaging vendors, and specialty providers
• Establish clear performance metrics and ensure accountability across all external partners

Quality and Compliance

• Ensure all studies are conducted in accordance with GCP, ICH guidelines, and global regulatory requirements
• Maintain inspection readiness and lead audit and inspection responses
• Implement quality oversight processes with a focus on data integrity, especially for imaging and functional endpoints

Operational Strategy and Scaling

• Contribute to overall clinical development strategy with an operational lens specific to ophthalmology
• Identify and implement innovative approaches to improve patient recruitment, retention, and site performance
• Support global expansion strategies, including geographic considerations for ophthalmology trials

Budget and Resource Management

• Develop and manage clinical operations budgets across multiple ophthalmology programs
• Forecast and allocate resources aligned with pipeline priorities
• Drive cost efficiency while maintaining high quality study execution

Qualifications

• Bachelor’s degree required. Advanced degree preferred
• 10+ years of clinical operations experience in biotech or pharma, with significant focus in ophthalmology (Retina)
• Proven experience leading global ophthalmology clinical trials, including retinal or anterior segment indications
• Strong expertise in ophthalmic endpoints such as BCVA, OCT, FAF, visual fields, and IOP
• Demonstrated success managing CROs, central reading centers, and imaging vendors
• Deep understanding of GCP, regulatory requirements, and ophthalmology-specific trial considerations
• Strong leadership, communication, and cross functional collaboration skills
• Ability to operate strategically while remaining hands on when needed