Director, Clinical Scientist - Ophthalmology
EyePoint
August 14, 2026
Remote
United States
Clinical Research and Development
Reporting to the Chief Medical Officer (remote).
Responsibilities:
- Implement Clinical Development Plans and Registrational Strategies for assigned products.
- Collaborate with Clinical Development and partnered CROs on clinical trial documents (protocol synopses/protocols, investigator brochures, informed consent templates, case report forms/EDC, procedure manuals, clinical study reports) ensuring compliance with ICH/GCP, federal/local regulations, and company SOPs.
- Assist with collection, review, and analysis of clinical trial data per interim and statistical analysis plans.
- Perform ongoing review of clinical data for safety/effectiveness trends and protocol adherence.
- Support preparation of regulatory submission documents (e.g., EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs, and other filings/meetings).
- Assist with authorship of abstracts/posters and publication of trial data per the program publication strategy.
- Support site initiation activities (site initiation visits, investigator meetings, monitoring plan development, annotated monitoring report templates, and submission of required documents).
- Support clinical trial recruitment by evaluating enrollment vs. targets and partnering with sites/clinical operations to meet/exceed targets.
- Assist with study milestones and study metrics.
- Ensure global trial conduct in compliance with global regulations, ICH, and GCP.
Qualifications:
- Advanced degree (life science/clinical/medical), PhD or PharmD.
- Minimum 10 years clinical development/research and R&D experience (preferred).
Required Skills/Knowledge:
- Strong understanding and application of clinical research procedures and GCP.
- Ophthalmology experience; familiarity with drug/device combination products.
- Experience across all phases of clinical drug development, including regulatory submissions.
- Ability to interpret scientific literature relevant to the portfolio.
- Strong communication, organizational, and interpersonal skills.
- Matrix/cross-functional teamwork experience.
- Independent decision-making and analytical skills.
Compensation:
- Pay range: $197,760–$249,947 USD.
Responsibilities:
- Implement Clinical Development Plans and Registrational Strategies for assigned products.
- Collaborate with Clinical Development and partnered CROs on clinical trial documents (protocol synopses/protocols, investigator brochures, informed consent templates, case report forms/EDC, procedure manuals, clinical study reports) ensuring compliance with ICH/GCP, federal/local regulations, and company SOPs.
- Assist with collection, review, and analysis of clinical trial data per interim and statistical analysis plans.
- Perform ongoing review of clinical data for safety/effectiveness trends and protocol adherence.
- Support preparation of regulatory submission documents (e.g., EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs, and other filings/meetings).
- Assist with authorship of abstracts/posters and publication of trial data per the program publication strategy.
- Support site initiation activities (site initiation visits, investigator meetings, monitoring plan development, annotated monitoring report templates, and submission of required documents).
- Support clinical trial recruitment by evaluating enrollment vs. targets and partnering with sites/clinical operations to meet/exceed targets.
- Assist with study milestones and study metrics.
- Ensure global trial conduct in compliance with global regulations, ICH, and GCP.
Qualifications:
- Advanced degree (life science/clinical/medical), PhD or PharmD.
- Minimum 10 years clinical development/research and R&D experience (preferred).
Required Skills/Knowledge:
- Strong understanding and application of clinical research procedures and GCP.
- Ophthalmology experience; familiarity with drug/device combination products.
- Experience across all phases of clinical drug development, including regulatory submissions.
- Ability to interpret scientific literature relevant to the portfolio.
- Strong communication, organizational, and interpersonal skills.
- Matrix/cross-functional teamwork experience.
- Independent decision-making and analytical skills.
Compensation:
- Pay range: $197,760–$249,947 USD.