Associate Director, Clinical Scientist

eGenesis; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

eGenesis is seeking a Clinical Scientist for its Clinical Development team to operationalize clinical programs. The role involves supporting clinical trials, collaborating across various teams, and ensuring compliance with regulatory standards. Candidates should have a Ph.D. or equivalent and experience in clinical research, with strong analytical and communication skills.

Qualifications

• 5+ years of experience in clinical research or drug development in a biotech setting.
• Solid understanding of clinical trial design and GCP guidelines.
• Experience working with vendors and clinical sites.

Responsibilities

• Support execution of Phase 1 EGEN-5784 Liver clinical trial.
• Contribute to protocol development in the EGEN-2784 Kidney program.
• Ensure data integrity and protocol adherence in clinical programs.

Skills

Analytical Skills

Communication

Collaboration

Education

Ph.D. or PharmD or Master's degree

Job description

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 Clinical Scientist 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