Associate Scientific Director, TB&B

Responsibilities

• Lead bioanalytical and biomarker strategies for multiple clinical development programs in China, ensuring compliance with NMPA/CDE requirements.
• Provide scientific and technical oversight of China-based and global bioanalytical vendors for method development, validation, and clinical sample testing.
• Serve as the subject matter expert for data analysis and regulatory submissions, including reviewing PK, immunogenicity, and biomarker results for IND/NDA/BLA packages.
• Act as the China regulatory and quality point-of-contact for bioanalysis and biomarkers, ensuring data integrity and inspection readiness.
• Lead and coordinate a matrix team of subject matter experts to execute bioanalytical deliverables in accordance with study timelines.
• Provide strategic input to global project teams regarding China-specific localization, bridging considerations, and immunogenicity risk assessment.

Requirements

• PhD with 10+ years of experience, MS with 16+ years, or BS with 18+ years of relevant experience (must include at least 7+ years of industry experience).
• In-depth expertise in bioanalytical chemistry, immunology, and drug development techniques.
• Proficiency in biomarker technologies such as immunoassays, genomics, flow cytometry, cell-based assays, or LC-MS/MS.
• Strong knowledge of global and China-specific regulatory guidance (NMPA/CDE) for method validation and sample testing.
• Proven experience overseeing China-based laboratories or CROs, including vendor qualification and governance.
• Fluency in both Chinese and English (written and spoken).

About the Company

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united in our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.