Associate Director/Director, Clinical Scientist

Role Summary

Associate Director/Director, Clinical Scientist at EyePoint, remote. Leads the design and execution of clinical development plans and registrational strategies for ocular products, collaborating with cross-functional teams and external CROs. Oversees the preparation of regulatory submissions, analysis of clinical trial data, and publication activities, and supports site initiation and patient recruitment. Requires an advanced life sciences degree and substantial experience in clinical development/research.

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 with Clinical Development and partnered Clinical Research Organizations (CROs) on all clinical trial documents, ensuring high-caliber documents in compliance with ICH/GCP standards/Federal and local regulations and company SOPs.
• Assist 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.
• Assist with 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.
• Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
• Assist with 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.
• Assist with 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.

Qualifications

• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP).
• Experience in ophthalmology and familiarity with drug/device combination products.
• Experience with all phases of clinical drug development including regulatory submissions.
• Ability to survey and interpret scientific literature related to the assigned portfolio of products.
• Strong communication, organizational and interpersonal skills.
• Successful work experience in a matrix team environment with cross-functional teams.
• Independent decision-making and analytical skills.
• Minimum of 5+ years of clinical development/research and R&D experience (preferred for Associate Director level).
• Minimum of 10 years of clinical development/research and R&D experience (preferred for Director level).

Education

• Advanced degree in life science/clinical/medical field, PhD or PharmD.