Associate Scientific Director, Translational Biomarkers&Bioanalytics

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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).