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About 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 an Associate Director, Translational Biomarker Lead Inflammation/ Autoimmune Disease, ECD where you will provide scientific and strategic leadership in developing the translational biomarker strategy, and plans to secure implementation for Inflammation and Autoimmune (AI) diseases programs in clinical and pre-clinical stages of 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) discovery research and physician-scientists and relevant partner lines and functions to identify and validate biomarkers relevant to patients in clinical studies.
Responsible for independently developing translational biomarker strategy and 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.
Secure implementation and delivery of data.
As part of the Translational Biomarker Research team, you will report to the Head of the team and work with the Gastrointestinal and Inflammation Therapeutic Area Unit (GI² TAU).

How you will contribute:

• 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 define candidate biomarkers for mechanisms 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, discovery research scientists, and 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 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, 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, 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.
  

Minimum Requirements/Qualifications:

• PhD or MD/PhD degree in a scientific discipline with 8+ years experience, or

• MS with 16+ years experience, or BS with 18+ years experience.
  

• At least 5 years of experience in clinical translational biomarker research.
  

• Outstanding expertise and depth of knowledge within Inflammation and Autoimmune diseases clinical translational and biomarker space.
  Dermatology, gastroenterology and/or rheumatology experience preferred.
  

• 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.

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