Global Biomarker Lead, Inflammation, GI2 TAU
Takeda
Bengaluru, Karnataka, India
Contract
Competitive
OfficeManager
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As Associate Director/Director, Global Biomarker Lead (GBL), Inflammation, ED&B GI2 TAU, you will
provide scientific and strategic leadership for the development and implementation of translational
biomarker strategies across preclinical and clinical-stage gastrointestinal and inflammation
portfolio programs. This highly visible, strategic, and matrixed role leads the Translational Sub-Team
(TST) and partners with GI-DDU research, physician scientists, and cross-functional stakeholders
to identify, validate, and implement biomarkers relevant to patients in clinical studies. The role is
responsible for independently developing translational biomarker plans as part of the overall asset
strategy across Discovery and Global Product Teams, supporting programs through clinical
development and post-market activities, and ensuring timely delivery of high-quality biomarker
data.
Key responsibilities:
•Partner with GI-DDU discovery research and physician scientists to design and execute
translational research that identifies and validates targeted pathways based on human data
and defines candidate biomarkers for mechanism of action and drug response.
•Lead translational biomarker strategy development and execution to support the clinical-
stage portfolio, including biomarker-driven clinical study design, implementation of novel
technologies, and incorporation of biomarker endpoints for decision-making in early-stage
clinical trials.
•Lead the Translational Sub-Team (TST) and provide matrix leadership across multiple
functional areas, working closely with physician scientists, clinical leads, clinical
pharmacologists, TBB, nonclinical scientists, and discovery research scientists to build
consensus around a fit-for-purpose biomarker strategy.
•Represent Translational and Biomarker Research on Project and Global Product Teams to
provide pharmacodynamic, disease and predictive biomarker strategy and support
translational medicine goals of the assigned programs in all phases of clinical
development.
•Contribute as a key member of project teams that provide strategic, technical, and
scientific leadership for program progression from discovery research through development
and serve as a subject-matter expert for clinical development and overall asset strategies.
•Implement fit-for-purpose validation for all clinical biomarker assays in partnership with the
biomarker assay group, and ensure high scientific quality of pharmacodynamic, prognostic,
and predictive biomarker data to drive program decision-making. Evaluate and apply state-
of-the-art scientific tools and cutting-edge technologies to drive innovation in biomarker
strategy execution.
•Maintain extensive knowledge of the research and development efforts from academic
institutions, competitor biopharmaceutical companies and fee-for-service bioanalytical
CROs for translational biomarker research.
•Responsible for the preparation and review of biomarker sections of candidate nomination
documents, clinical protocols and documents submitted to Regulatory Agencies.•Establish and maintain scientific dialogue with KOLs and clinical translational experts
across medical, academic, and regulatory communities.
Minimum Requirements/Qualifications:
•PhD in a scientific discipline with 7+ years of relevant experience.
•Deep expertise in translational biomarkers and multi-omics approaches within immune-
mediated inflammatory diseases.
•Demonstrated expertise in biomarker discovery, biomarker development, and translational
medicine, as evidenced by publications, regulatory submissions, and/or national or
international presentations.
•Excellent understanding of drug development, regulatory processes and clinical
development.
•Proven leadership ability, including experience leading teams within a matrix organization
and working independently.
•Strong analytical, oral and written communication, problem-solving, and interpersonal
skills.