(Associate) Director of Clinical Operations

RhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our programs target patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need.

The Associate Director/Director of Clinical Operations is accountable for supporting a cross-functional clinical development team to ensure the successful planning, execution, and close-out of clinical trials in the ophthalmology portfolio. This individual will manage and oversee internal and external study activities, managing and overseeing a CRO and other vendors. This position will report to the Head of Clinical Operations.

Tasks

• Lead the day-to-day management and oversight of clinical trials within the ophthalmology portfolio to ensure deliverables are met and within budget.
• Develop and maintain study timelines, enrollment projections, operational plans, and study budgets.
• Oversee and manage CRO and other external vendors.
• Contribute to or author relevant study documents such as the protocol, informed consent form, investigator brochure, clinical study reports and other documents and plans, as appropriate.
• Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews.
• Ensure studies are executed in accordance with protocol, GCP, company SOPs, and applicable regulatory requirements.
• Provide operational input into clinical development plans and portfolio strategy discussions.
• Participate in the development of clinical operations processes and SOPs.
• Establish and maintain strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs. Keep stakeholders appropriately advised on project status and emerging issues.
• Proactively identify emerging risks, issues and opportunities across programs before they become critical, applying robust analytical judgement to create clarity, frame options and translate insights into practical, outcome-oriented actions.
• Manage and develop clinical operations personnel as program advances and team expands.

Requirements

• Minimum of 8-10 years of experience in clinical operations with significant clinical trial experience globally across PhI – PhIII.
• Ability to build strong relationships with the sites and CRO.
• Ability to deal with ambiguity, and work in a dynamic, fast paced environment and adapt to changes that surface in program or project planning.
• Demonstrated self-starter and team player with strong interpersonal skills.
• Excellent written and verbal skills.
• Must display strong analytical and problem-solving skills, with strong attention to detail.
• Experience in ophthalmology and/or gene therapy preferred.

Benefits

Why Join Us

• Opportunity to help develop breakthrough therapies for patients with serious vision-threatening diseases.
• Work alongside a passionate, highly experienced team at the forefront of ophthalmology innovation.
• Meaningful impact in a growing biotech company.
• Collaborative, entrepreneurial culture where science and innovation drive decision-making.
• Candidates needs legally able to work in the US (US citizen or US work permit).