Associate Director Clinical Operations - Retina

Job Title: Associate Director Clinical OperationsLocation: San Francisco (Hybrid 1-3 days a week Onsite)Reports To: Executive Director, Clinical OperationsOverviewWe 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 ResponsibilitiesClinical Operations LeadershipProvide 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 staffDevelop and scale infrastructure, SOPs, and operational frameworks tailored to ophthalmic trialsCollaborate cross functionally with Clinical Development, Regulatory, Biostatistics, Data Management, and Medical AffairsTrial Execution and DeliveryOversee planning, startup, execution, and closeout of global ophthalmology trials across Phase I through Phase IIIEnsure delivery against timelines, budgets, and quality standardsManage study risks specific to ophthalmology, including enrollment challenges, variability in visual acuity endpoints, and imaging consistencyDrive site selection strategies focused on high enrolling ophthalmology centers and key opinion leader networksOphthalmology-Specific ExpertiseOversee implementation and standardization of ophthalmic endpoints such as BCVA, OCT imaging, visual field testing, and intraocular pressure measurementsEnsure proper vendor selection and oversight for central reading centers, imaging vendors, and specialized ophthalmic CRO capabilitiesMaintain consistency and quality in imaging data acquisition and grading across sitesGuide protocol development with a strong understanding of ophthalmology trial design and patient pathwaysVendor and CRO OversightLead selection, contracting, and oversight of CROs, central labs, imaging vendors, and specialty providersEstablish clear performance metrics and ensure accountability across all external partnersQuality and ComplianceEnsure all studies are conducted in accordance with GCP, ICH guidelines, and global regulatory requirementsMaintain inspection readiness and lead audit and inspection responsesImplement quality oversight processes with a focus on data integrity, especially for imaging and functional endpointsOperational Strategy and ScalingContribute to overall clinical development strategy with an operational lens specific to ophthalmologyIdentify and implement innovative approaches to improve patient recruitment, retention, and site performanceSupport global expansion strategies, including geographic considerations for ophthalmology trialsBudget and Resource ManagementDevelop and manage clinical operations budgets across multiple ophthalmology programsForecast and allocate resources aligned with pipeline prioritiesDrive cost efficiency while maintaining high quality study executionQualificationsBachelor’s degree required. Advanced degree preferred10+ 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 indicationsStrong expertise in ophthalmic endpoints such as BCVA, OCT, FAF, visual fields, and IOPDemonstrated success managing CROs, central reading centers, and imaging vendorsDeep understanding of GCP, regulatory requirements, and ophthalmology-specific trial considerationsStrong leadership, communication, and cross functional collaboration skillsAbility to operate strategically while remaining hands on when needed