Description
The PharmSci China Project Lead is responsible for coordination, alignment, and delivery of PharmSci/PGS related activities for China drug development programs.
This 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.
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.