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Associate Medical Director, Microbiome - GI DDU

Cambridge, Massachusetts


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Associate Medical Director, Microbiome - GI DDU

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Job ID R0012330 Date posted 09/11/2019 Location Cambridge, Massachusetts

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Job Description


This position requires an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making in both preclinical and clinical stages of drug development programs in gastrointestinal diseases preferably with experience in microbiome.  Responsibilities include partnering with drug discovery scientists and research project teams to identify biomarkers relevant to patients in clinical studies and partnering with Global Product Teams to develop a translational biomarker plan as part of the overall Asset Strategy.


  • Collaborate with medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy. Part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
  • Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response. Participate in the collaborative interactions between Clinical Development and drug discovery researchers at multiple sites to facilitate generation and implementation of clinical development strategies.
  • Represent Translational Research on Global Product Teams to contribute to the dose and biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational/experimental medicine approaches for clinical protocols.
  • Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
  • Maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies and fee-for-service bioanalytical companies for relevant GI biomarkers.
  • Evaluate, and use new scientific tools and ensure that technical and scientific standards meet state-of-the-art industry expectations.
  • Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies.
  • Support Medical Affairs and Late Stage development for identifying potential ways that the approved indication can be expanded.
  • 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 FDA, as required. Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.


  • Ph.D +10 years, or PharmD +12 years, or Masters +13 years or Bachelors +15 years of experience. Degree is expected in relevant scientific area, e.g., GI, Immunology, Pharmacology, Microbiology, Molecular Biology, Cell Biology.
  • More than 7 years of relevant industry experience in translational research
  • Recognized expertise in biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
  • Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational research strategies implemented in early clinical programs in a timely manner
  • An understanding of Proof-of-Concept and Proof-of-Mechanism clinical concepts and trial design
  • Should serve as a “highly credible technical expert” to outside functional areas
  • 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
  • Superior analytical, problem solving skills
  • Extraordinary oral and written communication skills
  • Exceptional interpersonal skills 


  • 25% National and International travel.


Cambridge, MA

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Full time

Job ID R0012330

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