Director Translational Biomarker Lead Inflammation/Autoimmune Disease, ECD GI
1 month ago
Takeda 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 Responsibilities- Develop and execute translational biomarker strategies to support clinical stage portfolio, including biomarker-driven clinical study design and implementation of novel technologies.
- Lead the 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.
- 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 assigned programs in all phases of clinical development.
- 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.
- Maintain extensive knowledge of 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.
- PhD degree in a scientific discipline with 10+ years of experience, or MS with 16+ years of experience, or BS with 18+ years of 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 Pharmaceuticals Full timeAbout the Role:Takeda Pharmaceuticals is seeking a highly skilled and experienced Director Translational Biomarker Lead to join our Early Clinical Development (ECD) team. As a key member of our team, you will be responsible for developing and implementing translational biomarker strategies for our Inflammation and Autoimmune (AI) disease programs.As a...
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda 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)...
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the Role:Takeda is seeking a highly skilled and experienced Director Translational Biomarker Lead Inflammation/Autoimmune Disease to join our Early Clinical Development team. As a key member of our research organization, you will provide scientific and strategic leadership in developing the translational biomarker strategy, plans, and implementation...
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