The Director/Senior Director will lead the development and execution of pharmacovigilance strategies to support late-stage clinical development and commercial product launch. This role involves overseeing safety operations, signal detection, regulatory compliance, and cross-functional governance to ensure an inspection-ready safety system.
The Manager of Statistical Programming oversees study-level programming deliverables and manages a team of internal or CRO programmers. They are responsible for developing CDISC-compliant datasets, TLFs, and reports while ensuring adherence to regulatory standards and project timelines.
The Manager, Quality Assurance manages GxP quality requirements across the product lifecycle, including clinical development, commercialization, and ongoing supply. They are responsible for reviewing production records, overseeing CMOs, and ensuring compliance with global regulatory standards.
The Sr. Medical Science Liaison is responsible for developing and maintaining professional relationships with key opinion leaders in the metabolic and oncology therapeutic areas. They provide scientific support, communicate clinical insights, and contribute to launch readiness plans while ensuring adherence to ethical and regulatory standards.
Lead the transition from clinical stage supply to a fully externalized global manufacturing and supply chain platform for biologics. Oversee vendor networks, manage the Plan of Record for clinical and commercial supply, and ensure regulatory compliance for global product launches.
