Global Biomarker Lead, Inflammation, GI2 TAU

Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA reporting to the Senior Director, Head Inflammation Biomarkers, ED&B GI2 TAU.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

As 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.

ACCOUNTABILITIES:

• 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.

EDUCATION AND EXPERIENCE:

• PhD in a scientific discipline with 7+ years of relevant experience.
• Deep expertise in translational biomarkers…