eGenesis, Inc.

Medical Director

• Support the design and implementation of early and late-stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous
• Develop and maintain clinical development plans that integrate preclinical, translational, and clinical data while ensuring alignment across cross-functional teams
• Design scientifically rigorous, operationally feasible, and cost-effective clinical protocols aligned with the overall clinical development plan
• Present clinical protocols, development plans, and study updates to internal governance committees and senior leadership
• Serve as the Clinical Science representative on cross-functional project teams
• Partner closely with the Medical Monitor to oversee study conduct, monitor study progress, and ensure protocol compliance
• Lead data review, evaluation, and analyses in collaboration with Data Management and Biostatistics and Statistical Programming teams
• Contribute to the preparation of clinical sections of regulatory submissions and supporting documents, including INDs, briefing documents, BLAs, Safety and Annual reports, and responses to regulatory agencies regarding questions about clinical development issues (e.g., safety or efficacy)
• Ensure compliance with applicable regulations, clinical R&D policies, SOPs and quality standards
• Support scientific due diligence activities, including preparing and presenting medically-sound strategies and plans associated with advanced opportunities
• Drive continuous improvement to enhance Clinical Development processes, study execution and cross-functional collaboration

Associate Director, Clinical Science