[Hiring] Associate Director/Director, Clinical Scientist @EyePoint Pharmaceuticals, Inc.

Role Description

This position is reporting to the VP, Clinical Development and is remote.

• 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
• Ensure 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
  • Annotated monitoring visit report templates
  • 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) 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.

Requirements

• 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.

Benefits

• Robust total rewards in a science-based entrepreneurial culture.
• Space for every voice and perspective to be heard in on-site and remote environments.