Associate Director/Director, Clinical Scientist
EyePoint
8 hours ago
Remote
United States
Clinical Research and Development
Primary responsibilities:
- Contribute to cross-functional implementation of 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, eCRFs/EDC systems, procedure manuals, clinical study reports) in compliance with ICH/GCP, federal/local regulations, and company SOPs.
- Assist in collection, review, and analysis of clinical trial data per interim and overall statistical analysis plans.
- Monitor clinical data trends for safety, effectiveness, and protocol adherence.
- Support preparation of submission documents for global health authorities (EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs, and other regulatory meetings/filings).
- Assist with authorship of meeting abstracts/posters and publication of clinical trial data per the program publication strategy.
- Support site initiation activities (site initiation visits, investigator meetings, monitoring plan development/implementation, annotated monitoring visit report templates, and submission of required documents prior to initiation).
- Assist recruitment strategies by evaluating enrollment vs. targets and working with investigational sites to meet/exceed targets with Clinical Operations.
- Assist with study milestones and study metrics with Clinical Operations.
- Ensure global trial conduct in compliance with global regulations, ICH, and GCP.
Required skills/knowledge:
- Strong understanding 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 survey and interpret scientific literature related to the product portfolio.
- Strong communication, organizational, and interpersonal skills.
- Experience working in matrix/cross-functional teams.
- Independent decision-making and analytical skills.
Education:
- Advanced degree in a life science/clinical/medical field (PhD or PharmD).
Experience:
- 5+ years clinical development/research and R&D (preferred for Associate Director level).
- 10+ years clinical development/research and R&D (preferred for Director level).
- Contribute to cross-functional implementation of 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, eCRFs/EDC systems, procedure manuals, clinical study reports) in compliance with ICH/GCP, federal/local regulations, and company SOPs.
- Assist in collection, review, and analysis of clinical trial data per interim and overall statistical analysis plans.
- Monitor clinical data trends for safety, effectiveness, and protocol adherence.
- Support preparation of submission documents for global health authorities (EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs, and other regulatory meetings/filings).
- Assist with authorship of meeting abstracts/posters and publication of clinical trial data per the program publication strategy.
- Support site initiation activities (site initiation visits, investigator meetings, monitoring plan development/implementation, annotated monitoring visit report templates, and submission of required documents prior to initiation).
- Assist recruitment strategies by evaluating enrollment vs. targets and working with investigational sites to meet/exceed targets with Clinical Operations.
- Assist with study milestones and study metrics with Clinical Operations.
- Ensure global trial conduct in compliance with global regulations, ICH, and GCP.
Required skills/knowledge:
- Strong understanding 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 survey and interpret scientific literature related to the product portfolio.
- Strong communication, organizational, and interpersonal skills.
- Experience working in matrix/cross-functional teams.
- Independent decision-making and analytical skills.
Education:
- Advanced degree in a life science/clinical/medical field (PhD or PharmD).
Experience:
- 5+ years clinical development/research and R&D (preferred for Associate Director level).
- 10+ years clinical development/research and R&D (preferred for Director level).