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Director – Translational Biomarker Lead – Inflammation/IBD
| Company | Takeda |
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| Location | Cambridge, MA, USA |
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| Salary | $174500 – $274230 |
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| Type | Full-Time |
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| Degrees | PhD, MD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- PhD and/or MD degree in relevant field with 10+ years of experience
- At least 7 years of experience in translational biomarker research
- Experience in Inflammatory disease (Dermatology, Respiratory, Atopic diseases), IBD (Fibrostenotic CD) biomarkers research
- 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
Responsibilities
- Partner with GI² DDU research scientists and GI² TAU physician-scientists in designing and executing Translational Research to discover and validate targeted pathways based on human data and define candidate biomarkers for mechanisms of action and drug response.
- Lead Translational Biomarker strategy development and execution to support the pre-clinical and 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 provide matrix leadership and enhance collaboration across multiple functional areas, working closely with physician-scientists, clinical leads, clinical pharmacologists, BST, discovery research scientists, regulatory, non-clinical and other functions 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 strategies 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 the progression of the 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 target engagement/pharmacodynamics, prognostic and predictive biomarker data to drive program decision-making.
- Evaluate and utilize state-of-the-art scientific tools and ensure implementation of 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 translational biomarker research.
- Responsible for the preparation and review of biomarker sections of candidate nomination, PRC documents, CDP, clinical protocols, ICFs 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, consortia, consultants, university representatives, NIH, and Regulatory Agencies, as required.
- Establish and maintain a scientific dialog with KOLs and clinical translational experts in medical, academic, and regulatory communities.
Preferred Qualifications
- Managerial experience desired.
