About The Position

The Associate Director/Director of Clinical Operations supports a cross-functional clinical development team in planning, executing, and closing out clinical trials in RhyGaze’s ophthalmology portfolio. The role manages internal and external study activities, including oversight of CROs and other vendors, and reports to the Head of Clinical Operations. The position leads day-to-day trial operations, maintains timelines, enrollment projections, operational plans, and budgets, and contributes to study documents as appropriate. It also supports clinical development planning and portfolio strategy, helps develop clinical operations processes and SOPs, and collaborates with global cross-functional colleagues to deliver programs on time, to a high standard, and within budget. The role identifies and addresses emerging risks and issues and manages and develops clinical operations personnel as programs advance and the team expands. Candidates must be legally able to work in the United States as a U.S. citizen or with a U.S. work permit.

Requirements

  • Minimum of 8–10 years of experience in clinical operations, with significant global clinical trial experience across Phase I–III.
  • Ability to build strong relationships with clinical sites and CROs.
  • Ability to work with ambiguity in a dynamic, fast-paced environment and adapt to changes in program or project planning.
  • Demonstrated self-starter and team player with strong interpersonal skills.
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving skills, with close attention to detail.
  • Must be legally able to work in the United States as a U.S. citizen or with a U.S. work permit.

Nice To Haves

  • Experience in ophthalmology and/or gene therapy.

Responsibilities

  • Lead day-to-day management and oversight of ophthalmology clinical trials to ensure deliverables are met and trials remain within budget.
  • Develop and maintain study timelines, enrollment projections, operational plans, and study budgets.
  • Oversee and manage CROs and other external vendors.
  • Contribute to or author study documents, including protocols, informed consent forms, investigator brochures, clinical study reports, and other documents and plans, as appropriate.
  • Ensure the Trial Master File (TMF) is appropriately established and maintained throughout each trial, including through periodic reviews.
  • Ensure studies are conducted in accordance with the protocol, GCP, company SOPs, and applicable regulatory requirements.
  • Provide operational input into clinical development plans and portfolio strategy discussions.
  • Participate in developing clinical operations processes and SOPs.
  • Collaborate with global cross-functional colleagues to support timely, high-quality, and within-budget program delivery, and keep stakeholders informed about project status and emerging issues.
  • Identify emerging risks, issues, and opportunities across programs, apply analytical judgment, frame options, and translate insights into practical actions.
  • Manage and develop clinical operations personnel as programs advance and the team expands.

Benefits

  • 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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