The Manager, Statistical Programming oversees statistical programming activities for clinical studies from planning through regulatory submission. They provide technical leadership, mentor staff, and ensure all programming deliverables meet quality, compliance, and CDISC standards.
The manager will oversee end-to-end safety case processing and reporting activities performed by external vendors to ensure drug safety compliance. They will also act as a liaison between the pharmacovigilance department and internal stakeholders while maintaining internal policies and quality standards.
The Senior Director provides strategic and operational leadership for analytical chemistry, overseeing CMC analytical methods, stability programs, and outsourced assays. They serve as the technical authority for drug substance and product characterization, ensuring compliance with regulatory standards from early development through commercial support.
The Senior Manager/Associate Director will lead end-to-end commercial supply planning and S&OP execution to ensure continuous product supply. This includes managing demand forecasts, inventory levels, and production planning while driving cross-functional alignment.
This role supports the establishment and management of a global supply chain for commercial pharmaceutical products, including production planning, logistics, and inventory strategy. It also involves implementing business processes to ensure regulatory compliance and successful product launches with external partners.
The Associate Director provides strategic and operational leadership for clinical safety activities, including oversight of safety vendors and regulatory reporting. They are responsible for managing aggregate safety reports, ensuring compliance with global regulations, and serving as a subject matter expert for internal and external stakeholders.
The Oncology Sales Specialist is responsible for executing commercial strategies and meeting sales objectives within the assigned territory. They will build relationships with oncology healthcare providers and collaborate with internal teams to support patient access and product commercialization.
The Associate Director/Director manages drug formulation technology transfers, scale-up, and manufacturing processes while serving as the primary technical liaison with external CDMOs. They are responsible for overseeing vendor governance, authoring CMC documentation for regulatory filings, and ensuring robust production processes.
