The Director of Analytical Development provides strategic and technical leadership for biologics programs, overseeing method development, validation, and lifecycle management. They ensure analytical readiness for regulatory submissions and commercialization while managing internal and external laboratory activities.
The Vice President of Program Management will lead the PM function and serve as the senior program leader for SAB-142, overseeing its late-stage development, BLA preparation, and commercial launch readiness. This role involves driving cross-functional execution across clinical, regulatory, manufacturing, and commercial teams while managing budgets, risks, and integrated development plans.
Lead end-to-end global pharmacovigilance activities for late-phase biologic programs, ensuring compliance with international safety guidelines. Oversee the authorship of critical regulatory documents including Integrated Safety Summaries for BLA and MAA filings.
Lead the strategic and operational execution of manufacturing for late-stage clinical and commercial biologic programs. Oversee CDMO partnerships, technology transfer, and regulatory CMC documentation to ensure reliable commercial supply.
