(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).