EyePoint · 2 days ago
Associate Director/Director, Clinical Scientist
EyePoint is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The role involves collaborating with cross-functional teams to implement Clinical Development Plans and ensuring compliance with regulatory standards throughout clinical trials.
BiotechnologyHealth CareMedicalPharmaceutical
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
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
Qualification
Required
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
Ability to survey and interpret scientific literature related to the assigned portfolio of products
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
Advanced degree in life science/clinical/medical field, PhD or PharmD
Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level
Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level
Company
EyePoint
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.
H1B Sponsorship
EyePoint has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$803.8MKey Investors
Silicon Valley BankOcumension TherapeuticsEssex Woodlands Healthcare Partners
2025-10-14Post Ipo Equity· $150M
2023-12-05Post Ipo Equity· $215.9M
2022-03-09Post Ipo Debt· $45M
Leadership Team
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