Associate Director, Clinical Science

eGenesis; Cambridge (MA); On-site; USD 175,000 - 226,000; Full time

Job summary

eGenesis, a Cambridge, MA biotechnology company, seeks an Associate Director, Clinical Science to lead planning, execution, and oversight of clinical programs within its advancing pipeline. You will design development strategies, support regulatory submissions, and drive cross-functional collaboration to ensure scientific integrity and regulatory compliance across studies.

With 7+ years in clinical science, you will partner with Medical Monitor, Regulatory Affairs, Data Management, and

Qualifications

• PharmD or PhD with 7+ years of clinical science experience in biotech/pharma or CRO environment.
• Experience in clinical development and/or translational science is required.
• Excellent communication and collaboration skills across internal teams and external partners.

Responsibilities

• Support the design and implementation of clinical projects ensuring scientific and medical content is rigorous.
• Develop and maintain clinical development plans integrating preclinical, translational, and clinical data.
• Design scientifically rigorous, operationally feasible, and cost-effective clinical protocols.
• Present protocols and study updates to governance committees and senior leadership.
• Serve as the Clinical Science representative on cross-functional project teams.
• Partner with the Medical Monitor to oversee study conduct and ensure protocol compliance.
• Lead data review and analyses with Data Management, Biostatistics and Statistical Programming teams.
• Contribute to regulatory submissions including INDs, BLAs, and regulatory responses.
• Ensure compliance with regulations, R&D policies, SOPs and quality standards.
• Drive continuous improvement of Clinical Development processes and study execution.

Skills

Clinical science

Leadership

Regulatory submissions

GCP

Cross-functional collaboration

Education

PharmD or PhD with 7+ years

Tools

Excel

PowerPoint

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.