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Job Description
Objective / Purpose:
Scientific leader with deep bioanalytical and biomarker expertise, accountable for building capabilities, shaping the strategic direction for bioanalytical and biomarker development and implementation, and ensuring timely, compliant delivery of PK, immunogenicity, and biomarker data for clinical trials in China. Serves as an expert across one or more technologies (e.g., immunoassays, cell-based assays, flow cytometry, LC-MS/MS, and genomics) and partners closely within TB&B and with cross-functional stakeholders (e.g., QPTS, Translational Medicine, Clinical Sciences, GRA) to advance clinical assets. Applies fit-for-purpose, context-of-use, and relevant regulatory principles to assay and biomarker strategies that enable timely, high-quality portfolio decisions.
Accountabilities:
- Lead the bioanalytical strategy and contribute to biomarker strategy for multiple clinical development programs in China. Independently design and execute deliverables as the bioanalytical and biomarker SME, ensuring regulated bioanalysis meets current global guidance and China requirements (e.g., NMPA/CDE expectations) and reflects local operational constraints (e.g., sample handling, shipment/export limitations, and data requirements).
- Provide scientific and technical oversight of bioanalytical vendors (China-based and global) for method development, optimization, validation, lifecycle management (PK, immunogenicity, biomarkers), and clinical sample testing supporting development and post-market commitments across GI&I, NS and Oncology. Partner with Quality to ensure vendor qualification, audit readiness, and adherence to GxP and applicable China regulations; ensure delivery is timely, scientifically sound, and inspection-ready.
- Provide SME support for data analysis and regulatory submissions, including China submissions and interactions (e.g., NMPA/CDE IND/NDA/BLA packages as applicable). Review PK, immunogenicity, and biomarker results; sample analysis reports; statistical analysis plans and outputs; and relevant sections of CSRs and submission documents (e.g., ISI, IND, briefing books, IB, IMPD/CCD, CTD). Draft and support responses to health authority questions related to PK, immunogenicity, and biomarkers.
- Serve as the China regulatory and quality point-of-contact for bioanalysis/biomarkers: interpret and apply China regulations and guidance for method validation and sample testing; ensure documentation, data integrity, and laboratory practices are inspection-ready; and align with study teams on compliant sample collection, storage, chain-of-custody, and cross-border shipment/export considerations.
- Apply fit-for-purpose and context-of-use principles in biomarker development, including clinical feasibility assessments, assay validation approaches, and implementation strategies to deliver key assays and data that inform portfolio and program decisions.
- Lead and coordinate a TB&B matrix team of subject matter experts and study logistics partners to plan and execute bioanalytical/biomarker deliverables in accordance with study timelines; represent TB&B on cross-functional project teams and keep TB&B leadership informed of progress, risks, and mitigation plans.
- Provide input to relevant clinical and regulatory documents by consolidating SME feedback (e.g., protocols, IND/NDA/BLA submissions, briefing books, IB, CSR) and support study start-up and database lock activities (e.g., ICF and data transfer agreements, sample reconciliation, data review/QC, and data transfer).
- Provide strategic bioanalysis and biomarker input and scientific expertise to global project teams, including China-specific localization/bridging considerations as needed, and lead immunogenicity risk assessment and mitigation planning from early development through commercialization across modalities and therapeutic areas.
- Provide strategic recommendations on biomarker technologies and outputs aligned with stakeholder needs.
- Provide program updates to the line leadership and study teams. Proactively manage and resolve issues, escalating critical risks and decisions in a timely manner.
- Build a strong cross-functional network across Takeda and enhance Takeda visibility by participating in external bioanalysis/biomarker forums, presenting at scientific meetings, and contributing to publications.
Education & Competencies (Technical and Behavioral):
- PhD in a relevant scientific discipline with 10+ years of experience, or MS with 16+ years, or BS with 18+ years (including 7+ years of industry experience).
- In-depth expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in the context of drug development.
- Outstanding expertise in one or more biomarker technologies (e.g., immunoassays, genomics, flow cytometry, cell-based assays, LC-MS/MS), with a current understanding of scientific advancements and evolving best practices.
- Current knowledge of global and China-specific regulatory guidance for bioanalytical/biomarker method validation and clinical/preclinical sample testing.
- Demonstrated ability to operationalize China regulatory expectations (e.g., NMPA/CDE) into fit-for-purpose bioanalytical plans, including inspection readiness, data integrity, and documentation standards.
- Experience overseeing China-based laboratories/CROs, including vendor selection/qualification support, governance, deviation management, CAPA follow-up, and partnership with Quality.
- Strong knowledge of allied fields critical to drug development (e.g., drug metabolism, pharmacology, toxicology, pharmaceutical sciences, and clinical bioanalysis). Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.
- Demonstrated ability to work effectively on multi-disciplinary, cross-functional project teams.
- Excellent collaboration and influencing skills with an enterprise mindset; able to navigate highly complex, matrixed environments to align stakeholders and deliver through strong cross-functional partnerships.
- Fluent in Chinese and English (written and spoken).
Locations
Shanghai, China
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
