Job description
Role Summary
The Pharm. Sci China Project Lead is responsible for coordination, alignment, and delivery of Pharm. Sci/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 Pharm. Sci 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 Pharm. Sci 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 Pharm. Sci execution plans.
- Manage Pharm. Sci deliverables across development phases, including CTA and NDA milestones. China–Global Strategy Alignment
- Act as the primary Pharm. Sci interface between global (PSTL/CDTL/PPL, global Pharm. Sci, 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 Pharm. Sci 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 Pharm. Sci 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 Pharm. Sci 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 Pharm. Sci 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 Pharm. Sci 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. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Medical