Preclinical Development Lead

Job Summary

A company is looking for a Lead, Preclinical Development in Gene and Cell Therapies.

Key Responsibilities

• Design and establish in vivo efficacy and safety studies for CGT drug candidates
• Oversee execution of non-GLP and GLP studies with external organizations and analyze nonclinical data
• Draft nonclinical sections of regulatory documents and provide scientific leadership in Research Project Teams

Required Qualifications

• PhD in a relevant life-science discipline with 9+ years of industry experience
• Experience with animal and in vitro models, and designing experiments for clinical predictions
• Strong understanding of molecular biology techniques and experience with biologics, particularly cell and gene therapies
• Deep understanding of regulatory guidance for IND/CTAs and experience in cross-functional team leadership
• Comfortable with Good Laboratory Practices and dynamic work environments