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Job description
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, angenetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in amulti-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
The Associate Director, Clinical Science is responsible for the planning, execution and operational oversight of clinical development programs supporting the advancement of eGenesis’ pipeline. Working with cross-functional teams, this role will ensure the scientific integrity, operational excellence and timely execution of clinical studies. The successful candidate will contribute to the design and execution of clinical development strategies, support regulatory submissions, and drive continuous improvement across clinical development processes and initiatives in a collaborative, science-driven biotech environment.
PRIMARY RESPONSIBILITIES
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
QUALIFICATIONS
PharmD or PhD with 7+ years of clinical science experience in a biotech or pharmaceutical company, or CRO environment
Experience in clinical development and/or translational science required
Strong 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
Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
Excellent oral and written communication skills, including proficiency with Excel and PowerPoint
Base pay range for this job is $175,000 - $226,000.
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.