Role Summary
The PharmSci China Project Lead is responsible for coordination, alignment, and delivery of PharmSci/PGS related activities for China drug development programs. The role ensures alignment between global PSPT/CDT strategy and China clinical, regulatory, and commercial objectives, enabling efficient, compliant, and on time China development and registration.
This position serves as the single point PharmSci integrator for assigned assets across development stages (CTA through NDA), working across global technical teams and China asset teams to drive execution and issue resolution.
Key Responsibilities
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.Regulatory & NDA Support
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.Qualifications & Experience
Education
Advanced degree (PhD, MS, or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.Experience
Solid experience in pharmaceutical development, CMC, or PharmSci related project leadership.Exposure to China drug development and registration pathways is highly desirable.Proven ability to work effectively in highly matrixed, global teams.,Skills & Competencies
Strong project and stakeholder management skills.Ability to synthesize complex technical and regulatory topics into clear, executable plans.Effective communicator across cultures and disciplines in Chinese and English.High sense of ownership, accountability, and execution focus.Comfortable operating in fast changing regulatory and development environments.Why This Role Matters
The PharmSci China Project Lead is essential to delivering China projects on time, with quality and regulatory success, while minimizing rework and inefficiency. This role directly enables China’s contribution to global development programs and ensures China specific needs are integrated early and effectively.
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