Takeda
Biotech
AssociateScientificDirector,TranslationalBiomarkers&Bioanalytics
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“Associate Scientific Director, Translational Biomarkers &Bioanalytics at Takeda. Skills: Bioanalytical, Biomarkers, Drug development, Regulatory guidance. Lead bioanalytical strategy. Contribute to biomarker strategy”
What You'll Achieve.
Timely delivery of data; High-quality portfolio decisions; Inspection-ready delivery; Inform portfolio decisions; Inform program decisions
Industry & Context.
Issue resolution; Risk mitigation
What They're Looking For.
Must Have
PhD in relevant scientific discipline with 10+ years of experience, MS with 16+ years of experience, BS with 18+ years of experience, 7+ years of industry experience, In-depth expertise in bioanalytical chemistry, In-depth expertise in immunology, In-depth expertise in bioanalytical techniques, Current knowledge of global regulatory guidance, Current knowledge of China-specific regulatory guidance, Demonstrated ability to operationalize China regulatory expectations, Experience overseeing China-based laboratories/CROs, Fluent in Chinese (written and spoken), Fluent in English (written and spoken)
Nice to Have
MS with 16+ years of experience, BS with 18+ years of experience, 7+ years of industry experience, Outstanding expertise in one or more biomarker technologies, Current understanding of scientific advancements, Current understanding of evolving best practices, Experience with vendor selection/qualification support, Experience with governance, Experience with deviation management, Experience with CAPA follow-up, Experience with partnership with Quality
What You'll Do.
Lead bioanalytical strategy
Contribute to biomarker strategy
Ensure regulated bioanalysis meets guidance
Reflect local operational constraints
Provide scientific oversight
Provide technical oversight
Manage method lifecycle
Test clinical samples
Support post-market commitments
Ensure vendor qualification
Ensure audit readiness
Ensure China regulatory adherence
Ensure timely delivery
Ensure scientifically sound delivery
Ensure inspection-ready delivery
Support data analysis
Support regulatory submissions
Support China submissions
Support China interactions
Review statistical analysis plans
Review submission documents
Interpret China regulations
Apply China regulations
Ensure documentation standards
Align with study teams
Apply fit-for-purpose principles
Apply context-of-use principles
Perform clinical feasibility assessments
Inform portfolio decisions
Inform program decisions
Coordinate matrix teams
Keep TB&B leadership informed
Consolidate SME feedback
Support study start-up
Support database lock
Provide strategic input
Provide scientific expertise
Bridge China considerations
Lead immunogenicity risk assessment
Lead mitigation planning
Provide recommendations
Align with stakeholder needs
Provide program updates
Build cross-functional network
Enhance Takeda visibility
Participate in forums
Contribute to publications
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Cross-functional project teams; Matrix team; Study teams; Global project teams
Communication Scope
Written communication; Spoken communication; Scientific documents; Scientific meetings
Process & Methodology
Program management
Full Job Description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s [Privacy Notice](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **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 commi
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