(Associate) Director of Clinical Operations

RhyGaze AG; Philadelphia (Philadelphia County); On-site; USD 200,000 - 280,000; Full time

Benefits offered by this job

Breakthrough therapies

Experienced team

Meaningful impact

Collaborative culture

US work eligibility

Job summary

RhyGaze, a biotech company advancing gene therapies for blinding retinal diseases, is seeking an Associate Director/Director of Clinical Operations. You will lead day-to-day management of ophthalmology trials, oversee CROs and vendors, and ensure trials run on time and within budget.

You will develop study timelines, enrollment projections, study budgets, and contribute to protocol, ICF, reports, and regulatory documents while maintaining a compliant TMF and collaborating with global teams.

Qualifications

• 8–10 years in clinical operations with global PhI–PhIII experience.
• Proven ability to manage sites and CROs.
• Comfort with ambiguity in a fast-paced environment.
• Strong written and verbal communication.
• Analytical and detail-oriented with problem-solving skills.
• Experience in ophthalmology or gene therapy preferred.

Responsibilities

• Lead day-to-day management of ophthalmology trials and ensure deliverables and budget.
• Develop study timelines, enrollment projections, and budgets.
• Oversee CROs and external vendors.
• Contribute to study documents (protocols, ICFs, CRFs, final reports).
• Ensure TMF setup and ongoing maintenance.
• Ensure trials comply with protocol, GCP, SOPs, and regulations.
• Provide operational input into development plans and portfolio strategy.
• Develop clinical operations processes and SOPs.
• Collaborate with cross-functional teams globally to deliver programs on time and budget.
• Identify risks and propose actionable mitigations.
• Develop and mentor clinical operations staff as teams grow.

Skills

Clinical operations

Vendor management

Budget management

Cross-functional leadership

GCP compliance

Stakeholder management

Risk management

Team leadership

Education

Bachelor's degree in life sciences

Tools

EDC systems

CTMS

Regulatory submissions software

Job description

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).