Director, Clinical Scientist - Ophthalmology

About the role

The Clinical team at EyePoint drives the advancement of innovative therapies to help improve the lives of patients living with serious retinal diseases. This team leads the design and execution of patient-centric clinical trials, while managing robust safety and clinical data to produce high-quality, reliable insights that support regulatory and product development decisions. With a strong focus on safety, accessibility, and data integrity, the function helps accelerate the delivery of meaningful, vision-preserving treatments to patients.

Primary Responsibilities

• Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio.
• Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs.
• Aid in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
• Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials.
• Aid in the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
• Aid in the preparation of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
• Aid in all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
• Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations.
• Aid in study milestones and study metrics in collaboration with clinical operations.
• Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines.

Primary Skills and Knowledge

• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
• Experience in ophthalmology and familiarity with drug/device combination products.
• Experience with all phases of clinical drug development including regulatory submissions.
• Strong communication, organizational and interpersonal skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Independent decision-making and analytical skills are required.

Level of Education and Experience

• Minimum of 10 years of clinical development/research and R&D experience preferred.

Pay Range

$197,760 USD - $249,947 USD