The Executive Director will lead global pharmacovigilance operations for late-phase biologics, ensuring compliance with international regulatory guidelines. They will oversee signal detection, manage safety reporting workflows, and author critical regulatory documents such as Integrated Safety Summaries for BLA and MAA filings.
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.
The Clinical Sample Manager oversees the planning and execution of global clinical trial laboratory services and vendor management. This includes managing sample workflows, ensuring regulatory compliance, and coordinating data transfers from vendors to internal systems.
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.
