Associate Director, CMC Competitive Intelligence Management
Band
Level 5
Job Description Summary
As a TPPM China project leader, focuses on CMC technical project management supporting drug development for the Dev. China and BR China portfolio. The candidate should have solid CMC technical background and 5+ years working experience in the relevant drug development business in collaboration with clinical team. Additional knowledge and experience in CMC Intelligence management is preferred for gathering, analyzing, and synthesizing strategic corporate insights to fast evolving China local pharma industry with the purpose of support to China or global management to develop TRD footprint strategy in more efficient way.
Job Description
Major accountabilities:
- CMC Technical Management
- Align with global CMC development plan, drive the implementation for China CTA / NDA submission.
- Early identification of China specific technical / regulatory requirements and mitigate the risks in collaborative way.
- Follow up the CMC technical trends and adapt to the local regulatory evolving, keep fluent communication with global CMC community.
- Develop actionable insights to guide product development and life-cycle planning.
- Strategic Alignment
- Support for CMC leadership to integrate CMC technical development considerations into decision-making processes.
- Support fast-to-market initiatives by anticipating industry shifts and risks.
- Corporate intelligence Enablement
- Work with local NVS Line Functions (e.g regulatory, external business management and P&O ), TRD China technical local networks and global Intelligence team to align on targeted topics supporting China and global business strategy development.
- Stakeholder Engagement
- Communicate insights effectively to cross-functional and regional teams and governance forums.
- Build strong relationships with internal and external partners to ensure alignment.
Minimum Requirements:
Education:
- Advanced degree in Pharmaceutical Sciences, Chemistry, Biology, or related field.
- Experience:
- 5+ years in CMC, competitive intelligence, or related pharmaceutical functions.
- Proven track record in data analysis, strategic planning, and stakeholder engagement.
- Technical Skills:
- Proficiency in CI tools, data visualization, and analytics platforms.
- Understanding of regulatory requirements and global CMC standards.
Skills Desired
Budget Management, Coaching Skills, Data Science, Experiments Design, Laboratory, Problem Solving Skills, Process Simulation, R&D, Waterfall Model