Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily management and supervision of clinical trials within the ophthalmology portfolio to guarantee that deliverables are achieved and remain within budget.

• Create and uphold study timelines, enrollment forecasts, operational strategies, and study financial plans.

• Supervise and coordinate with CROs and other external partners.

• Contribute to or draft study-related documents, such as protocols, informed consent forms, investigator brochures, clinical study reports, and other plans and documents.

• Ensure the Trial Master File is properly established and maintained throughout the trial, including regular reviews.

• Guarantee that studies are conducted in alignment with protocols, GCP, company SOPs, and relevant regulatory standards.

• Provide operational insights into clinical development plans and strategies for the portfolio.

• Engage in the development of clinical operations processes and standard operating procedures (SOPs).

• Foster and sustain collaboration with global cross-functional teams to ensure timely, high-quality, and budget-compliant program execution.

• Keep stakeholders informed about project progress and any emerging issues.

• Identify potential risks, issues, and opportunities across programs, translating insights into actionable strategies.

• Manage and mentor clinical operations staff as the program progresses and the team grows.

⛳️ Requirements

• A minimum of 8-10 years of experience in clinical operations, with extensive clinical trial experience on a global scale across PhI–PhIII.

• Capability to establish robust relationships with sites and CROs.

• Ability to navigate ambiguity and function in a fast-paced, dynamic environment while adapting to changes in program or project planning.

• Proven self-starter and team player with exceptional interpersonal skills.

• Outstanding written and verbal communication abilities.

• Strong analytical and problem-solving capabilities, with meticulous attention to detail.

• Experience in ophthalmology and/or gene therapy is preferred.

• Candidates must be legally authorized to work in the US (US citizen or possess a US work permit).

🏝️ Benefits

• Opportunity to contribute to the development of groundbreaking therapies for patients with serious vision-threatening conditions.

• Collaborate with a dedicated, highly skilled team at the forefront of ophthalmology innovation.

• Make a meaningful impact within a growing biotech company.

• Enjoy a collaborative, entrepreneurial culture where science and innovation drive decision-making.