The Senior Director will provide strategic and operational leadership for the development of regulatory documents supporting late-stage biologics programs. This includes managing BLA/MAA submissions, ensuring compliance with global regulatory guidelines, and coordinating cross-functional teams to meet submission milestones.
The Senior Accountant is responsible for managing the monthly, quarterly, and annual financial close processes while ensuring compliance with U.S. GAAP and SOX internal controls. They will also prepare financial statements, support SEC reporting, and collaborate with cross-functional teams to maintain accurate financial records.
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.
The Clinical Trial Manager oversees the planning, implementation, and management of clinical trials to ensure regulatory compliance and efficiency. This includes coordinating cross-functional teams, managing external vendors, and maintaining study budgets and timelines.
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.
Lead the strategic development and delivery of high-quality regulatory documents, including BLAs and MAAs, for biologic candidates. Coordinate cross-functionally to ensure submission readiness and maintain consistency in scientific messaging for global health authorities.
