Clinical Science Lead, Associate Director

eGenesis

Cambridge (MA)

On-site

USD 175,000 - 226,000

Full time

14 days+

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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.