Clinical Development Represent PV during internal cross functional and external vendor meetings. Independently provide input to clinical development planning activities. Ensure consistent safety monitoring approach in line with industry standards. Lease with colleagues across functions to support collaborative workflows. Clinical Safety Proactively review clinical safety

In collaboration with regulatory leads and cross functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Incorporate regulatory strategy and well positioned content into high quality submissions to suppo

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

Lead the statistical strategy for projects and participate as a core member on clinical study teams. Be accountable and responsible for the statistical design, analysis plans, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 1 4 clinical trials including integrated analyses across trials. Initiate, drive and implement novel met