[Remote] Director, Clinical Scientist

Note: The job is a remote job and is open to candidates in USA. EyePoint is an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The Director, Clinical Scientist will contribute to the implementation of Clinical Development Plans and collaborate with cross-functional teams to ensure compliance with clinical trial standards and regulatory submissions.ResponsibilitiesContribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolioCollaborate 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 SOPsAssist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plansEnsure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trialsAssist 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 requiredAssist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical programAssist 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 initiationActively 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 operationsAssist with study milestones and study metrics in collaboration with clinical operationsEnsure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelinesSkillsA complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is requiredExperience in ophthalmology and familiarity with drug/device combination productsExperience with all phases of clinical drug development including regulatory submissionsAbility to survey and interpret scientific literature related to the assigned portfolio of productsStrong communication, organizational and interpersonal skills are requiredSuccessful work experience in a matrix team environment with cross functional teams is requiredIndependent decision-making and analytical skills are requiredAdvanced degree in life science/clinical/medical field, PhD or PharmDMinimum of 10 years of clinical development/research and R&D experience preferredCompany OverviewEyePoint (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. It was founded in 1987, and is headquartered in Watertown, Massachusetts, USA, with a workforce of 51-200 employees. Its website is http://www.eyepointpharma.com/.Company H1B SponsorshipEyePoint has a track record of offering H1B sponsorships, with 4 in 2024, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.