Role: Vice President and Program Lead for MGX-001, overseeing the clinical development from Phase 1/2 to BLA filing in gene editing for hemophilia A.
Responsibilities:
define and execute the development strategy, lead cross-functional teams including clinical, regulatory, CMC, and manufacturing, develop integrated timelines and budgets, manage regulatory interactions (IND, BLA, international filings), ensure GxP compliance, and communicate progress to executives and the Board.
Requirements:
advanced degree (PhD, PharmD, MD, MS), 15+ years in biopharma with at least 5 years leading drug development programs, experience in regulatory submissions, program management, and cross-functional leadership; familiarity with GCP, GMP, CMC, ICH guidelines; prior experience in publicly traded biotech preferred.
HighValue:
gene editing, hemophilia A, Phase 1/2, BLA preparation, regulatory strategy, GMP manufacturing, cross-functional team leadership, public company environment, international travel, based in Emeryville, CA.
#J-18808-LjbffrVP, Program Team Lead in emeryville at Unknown Company
This position is listed as full time and onsite.