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Director, Translational Biomarker Lead, IBD ()

Company: Takeda Pharmaceutical
Location: North Chelmsford
Posted on: August 7, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Translational Biomarker Lead, IBD in our San Diego, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

This position requires an acknowledged technical and strategic leader whose primary role is to provide scientific and strategic leadership in developing the translational biomarker strategy for the IBD (including fistulizing, stricturing, and fibrostenosing) pipeline programs in the preclinical and clinical stages. This is a highly visible, strategic and matrixed role, responsible for leading a team and partnering with Gastro-Intestinal drug discovery unit (GI-DDU) research and physician scientists and project teams to identify and validate biomarkers relevant to patients in clinical studies. Responsible for independently developing translational and biomarker plans as part of the overall Asset Strategy in the Global Product Teams through all stages of clinical development and post-market activities.

POSITION ACCOUNTABILITIES:

  • 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 surrogates of drug efficacy.
  • Lead Translational Biomarker strategy development and execution to support the clinical stage portfolio, including the biomarker driven clinical study design, implementation of novel technologies and incorporation of biomarker endpoints for decision making in early-stage clinical trials.
  • Manage a team of junior colleagues and collaborate across multiple sites and functional areas, working closely with physician scientists, clinical leads, clinical pharmacologists 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 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 and ensure high scientific quality of pharmacodynamic, prognostic and predictive biomarker data. 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 relevant IBD (including fistulizing, stricturing, and fibrostenosing) 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.
    DIMENSIONS AND ASPECTS:

    Technical/Functional (Line) Expertise
    • Outstanding expertise and depth of knowledge within IBD, fistulizing, stricturing, fibrostenosing disease and translational biomarkers applications.
    • Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technology, new research portfolio, and new partnership).
      Leadership
      • Has significant organizational leadership responsibility, including primary responsibility for representing the Translational Biomarker Function on project teams and senior management meetings for a defined function, department, or research area.
      • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
        Decision-making and Autonomy
        • Independently manages workload and expectations.
        • Scientifically independent.
        • Scientific driver for research strategy that impacts group internally and outside area of function.
          Interaction
          • Initiates and leads external interactions and collaborations.
          • Frequent contact with internal and external personnel at various management levels.
            Innovation
            • Determines methods on new assignments; makes strategic recommendations on projects.
              Complexity
              • Operate in matrix environment representing Translational Biomarker function on discovery and development teams.
                TRAVEL REQUIREMENTS:
                • Ability to drive to or fly to various meetings, including overnight trips. Some international travel may be required.
                • Requires approximately 15 - 25% travel.
                  EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
                  • PhD and/or MD degree in relevant field with 10+ years of experience.
                  • At least 5 years of experience in translational biomarker research. Managerial experience desired.
                  • Experience in any combination of the following areas is required: IBD-including fistulizing, stricturing, fibrostenosing diseases, fibrosis biomarkers research (multiple openings at different levels commensurate with experience).
                  • 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.
                    WHAT TAKEDA CAN OFFER YOU:
                    • 401(k) with company match and Annual Retirement Contribution Plan
                    • Tuition reimbursement Company match of charitable contributions
                    • Health & Wellness programs including onsite flu shots and health screenings
                    • Generous time off for vacation and the option to purchase additional vacation days
                    • Community Outreach Programs
                      Empowering Our People to Shine

                      Discover more at

                      No Phone Calls or Recruiters Please.

                      This job posting excludes CO applicants.

                      EEO Statement

                      Takeda 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.

                      Locations

                      San Diego, CA

                      Boston, MA

                      Worker Type

                      Employee

                      Worker Sub-Type

                      Regular

                      Time Type

                      Full time

Keywords: Takeda Pharmaceutical, Boston , Director, Translational Biomarker Lead, IBD (), Executive , North Chelmsford, Massachusetts

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