Director Translational Biomarker Lead Inflammation/Autoimmune Disease, ECD GI

5 days ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time
About the Role

Takeda is seeking a highly skilled Director Translational Biomarker Lead to join our team in Boston, MA. As a key member of our Translational Biomarker Research team, you will provide scientific and strategic leadership in developing the translational biomarker strategy, 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.
  • 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.
Requirements
  • 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.
About Takeda

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.

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