PepGen
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The Director / Associate Director of Biostatistics will lead statistical analysis for PepGen’s clinical development programs, manage CROs, develop trial protocols, and contribute to regulatory submissions and publications. The role demands collaboration with various teams and advanced competencies in statistical methodologies.
The Manager, Quality Systems is responsible for the development and maintenance of quality management systems supporting clinical trials. This includes managing supplier qualifications, conducting quality audits, ensuring compliance with FDA regulations, and maintaining quality agreements. Strong communication, organizational skills, and experience in a pharmaceutical/biotech environment are essential.
The Associate Director, Quality Control will lead QC activities for PepGen’s pipeline, oversee testing at CMOs, manage stability programs, and support regulatory filings while mentoring junior QC scientists and collaborating with cross-functional teams.