Directs the operations of multiple units and departments by identifying customer and operational needs; analyzing resources, costs, and forecasts and incorporating them into business plans; engaging strategic, cross-functional business units to champion and drive support for business plans and priorities; translating business strategy into actionable business requirements.
The successful candidate will demonstrate effective problem solving, strong understanding of regulatory, excellent interpersonal/collaboration skills, the ability to prioritize multiple tasks and lead in a matrix team environment.
Leading project teams from pre-IND to Phase III Go to deliver first- and best-in-class therapeutic molecules for pivotal clinical trials to enable successful global development and commercialization of gRED molecules.
Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc.
Work closely with business units, project management team and marketing to ensure coordination of efforts and ensure good communication with all parties. Help set up BU visits and stay involved when customers visit China.
Lead or support compliance audits at PTR and of PTR processes (regulatory change assessment, TRIC, APQR, etc.), lead and coordinate audit response teams and take ownership for audit observations closure.
The Project Director is responsible for the overall direction, management and financial outcome of their projects. Serve as a liaison between the office and field, while coordinating staffing and movement of field personnel.