Associate Director, Clinical Science

Company Mission
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.

Position Summary
eGenesis is seeking a highly motivated and experienced Associate Director of Clinical Science to join our Clinical Development team to play a key role in operationalizing eGenesis’ clinical programs across the pipeline. The Clinical Scientist will work cross-functionally with Clinical Operations, Regulatory, Pre-Clinical and Translational to execute study protocols and collect robust and interpretable data throughout the programs.

Primary Responsibilities

• Support the execution of the Phase 1 EGEN-5784 Liver clinical trial, ensuring adherence to regulatory and scientific standards
• Be a key contributor to protocol development in the EGEN-2784 Kidney program
• Collaborate with Clinical Operations to optimize the protocol and study-related documents, site selection, enrollment, and ensure protocol adherence and data integrity in all clinical programs
• Work with internal stakeholders including Clinical Development, Regulatory Affairs, Non-Clinical, and Translational teams to support study strategy and execution
• Contribute to addressing scientific and procedural questions from sites related to data collection and assessments in the clinical trials
• Interact with vendors conducting specialized testing or assays; ensure execution aligns with protocol and data quality requirements
• Serve as the first-level reviewer of clinical data to ensure completeness, interpretability, and alignment with study endpoints, identifying gaps or inconsistencies and work cross-functionally to resolve them
• Integrate and align data from external labs, registries, and other sources for comprehensive analysis
• Prepare clinical data summaries for internal and external presentation, and contribute to regulatory submissions
• Support development of responses to regulatory agencies as part of cross-functional submission teams
  
  
  
  
  

Basic Qualifications

• Ph.D., PharmD, RN, Master's degree with 5+ years of experience in clinical research or drug development in a biotech setting
• Solid understanding of clinical trial design, data collection standards, and GCP guidelines
• Strong analytical skills with the ability to analyze and compile complex clinical data
• Strong experience working with vendors and clinical sites
• Excellent communication and collaboration skills with both internal teams and external partners