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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 across global development programs. Serves as an expert across one or more technologies with one of them being mass spectrometry (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 local, EU, and global 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 global clinical development programs. Independently design and execute deliverables as the bioanalytical and biomarker SME, ensuring regulated bioanalysis meets current global guidance and applicable local/EU regulatory requirements where relevant and reflects local operational considerations for a Poland-based role (e.g., sample handling, shipment/export limitations, and data requirements).
Provide scientific and technical oversight of bioanalytical vendors (global and, where applicable, Poland/EU-based) for method development, optimization, validation, lifecycle management (PK, immunogenicity, biomarkers), and clinical sample testing su

📌 Associate Director (Bengaluru)
🏢 Takeda
📍 Bengaluru