Director of Translational Biomarker Research Inflammation/Autoimmune Disease
4 weeks ago
Takeda is seeking a highly skilled Director Translational Biomarker Lead Inflammation/Autoimmune Disease to join our team. As a key member of our Translational Biomarker Research team, you will be responsible for leading the development of translational biomarker strategies, plans, and implementation for Inflammation and Autoimmune (AI) diseases programs in preclinical and clinical stage development.
Key Responsibilities- Partner with GI-DDU discovery research and physician scientists in designing and executing Translational Research to discover and validate targeted pathways based on human data and to define 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 Translational subteam (TST) and matrix leadership and collaboration across multiple functional areas, working closely with physician scientists, clinical leads, clinical pharmacologists, BST and nonclinical and discovery research scientists to build consensus for 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 the project teams that provide strategic, technical and scientific leadership for progression of program from discovery research through development and contribute as a subject-matter expert for clinical development and overall asset strategies.
- Implement fit-for-purpose validation for all clinical biomarker assays with BST and ensure high scientific quality of pharmacodynamic, prognostic and predictive biomarker data to drive program decision-making. Evaluate and utilize state-of-the-art scientific tools and ensure implementation cutting-edge technology to drive innovation in the execution of biomarker strategy.
- Maintain extensive knowledge of the research and development efforts from academic institutions, competitor biopharmaceutical companies and fee-for-service bioanalytical CROs for MASH fibrosis translational biomarker research.
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies.
- Support Business Development efforts by evaluating potential in-licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with Regulatory Agencies, as required.
- Establish and maintain scientific dialog with KOLs and clinical translational experts in medical, academic and regulatory communities.
- PhD degree in a scientific discipline with 10+ years experience, or
- MS with 16+ years experience, or BS with 18+ years experience.
- At least 7 years of experience in translational biomarker research. Managerial experience desired.
- Outstanding expertise and depth of knowledge within inflammation and Autoimmune diseases translational and biomarker space.
- Recognized expertise in biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations.
- Excellent understanding of drug development, regulatory processes and clinical development.
- Strong leadership abilities and proven ability to lead a team within a matrix organization as well as work independently.
- Strong analytical, oral and written communication, problem solving and interpersonal skills.
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is a global pharmaceutical company committed to transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled and experienced Director Translational Biomarker Lead Inflammation/Autoimmune Disease to join our team.Key ResponsibilitiesDevelop...
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