Associate Director, Clinical Science
Cambridge, MA
Clinical Development /
Full-Time /
On-site
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
