Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU
Takeda
Summary
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.
Job description
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 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.
Requirements
- 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.
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.