Note: The job is a remote job and is open to candidates in USA. RhyGaze is hiring an Associate Director/Director of Clinical Operations to support its cross-functional clinical development team. The role oversees planning, execution, and close-out of ophthalmology clinical trials, including CRO and vendor management, study operations, and team development.

Responsibilities

• 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

Skills

• 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
• Candidates needs legally able to work in the US (US citizen or US work permit)
• Experience in ophthalmology and/or gene therapy preferred

Benefits

• Remote work
• 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.

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