Director Translational Biomarker Lead Liver disease - MASH fibrosis, ECD GI -TAU

Company: Takeda
Location: Boston
Posted on: November 13, 2024

Job Description:

Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Director, Translational Biomarker Lead where you will provide scientific and strategic leadership developing the translational biomarker strategy, plans and to secure implementation for diseases in liver (NASH, AATD, etc.), IBD (Fibrostenotic CD), skin (Scleroderma, etc.) and MASH fibrosis programs in preclinical and clinical stage development. This is a highly visible, strategic and matrixed role, responsible for leading the Translational subteam (TST) partnering with Gastro-Intestinal drug discovery unit (GI-DDU) research and physician scientists and relevant functions to identify and validate biomarkers relevant to patients in clinical studies. You will also independently develop translational biomarker plans as part of the overall Asset Strategy in the Discovery and Global Product Teams through all stages of clinical development and post-market activities. As part of the Gastrointestinal and Inflammation Therapeutic Area Unit (GI --TAU), you will report to the Head, Early Clinical Development (ECD), GI, and work with GI --TAU organization.How you will contribute:

• Partner with GI-DDU discovery research and physician scientists 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 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 provides 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.Minimum Requirements/Qualifications:
  • 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.
  • Experience in inflammation and Autoimmune diseases.
  • Outstanding expertise and depth of knowledge within Liver disease - MASH fibrosis.
  • 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.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeEEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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