Portfolio & Project Leadership
• Lead and coordinate PharmSci China activities for assigned small molecule, large molecule, or vaccine programs, ensuring delivery against China project milestones and timelines.
• Align global PSPT/CDT strategies with China development needs and translate global plans into actionable China PharmSci execution plans.
• Manage PharmSci deliverables across development phases, including CTA and NDA milestones.
China–Global Strategy Alignment
• Act as the primary PharmSci interface between global (PSTL/CDTL/PPL, global PharmSci, PGS, etc.) and China asset teams.
• Collect China-specific inputs from local functions and propose China aligned development strategies to PSPT/CDT leadership.
• Communicate global strategy decisions and updates back to China teams clearly and promptly.
• Lead preparation and execution of China NDA PharmSci strategies, including kickoff, planning, and execution.
• Drive development and alignment of JX/JS importation specifications, working with global and China teams to address method gaps, agency feedback, etc.
• Proactively identify risks related to testing readiness, sample availability, long lead time items, and regulatory expectations.
Execution & Issue Management
• Manage deliverables, timelines, and dependencies, ensuring early visibility of risks and mitigation plans.
• Rapidly respond to changes in China regulatory requirements, clinical protocols, or commercial timelines, and support updates to PharmSci plans accordingly.
• Support accelerated China development strategies (e.g., shortened trials, parallel activities) where applicable.
Governance, Communication & Knowledge Sharing
• Facilitate regular alignment meetings to drive execution and decision making across stakeholders.
• Contribute to and leverage China development playbooks, whitepapers, and technical guidance to promote consistency and best practices.
• Ensure accurate documentation, communication, and escalation of key PharmSci issues.