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Associate Director, Translational Biomarker Lead, IBD - Entyvio

Company: Takeda Pharmaceuticals
Location: San Diego
Posted on: January 27, 2023

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 Takedas 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 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 an Associate Director where you will provide scientific and strategic leadership in developing the biomarker strategy for the IBD focused on Entyvio also including pipeline programs in the preclinical, clinical stages and post-registration assets. You will also lead 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. As part of the GI DDU, you will report to the VP & Head of Translational Medicine & Biomarker Research.How you will contribute:

  • Accountable for Translational Biomarker strategy and implementation in partnership with the Global Medical Affairs colleagues and cross-functional team working on Global IEP as a part of the Global IBP for Entyvio.
  • 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 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 an important 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.
  • Establish and maintain scientific dialog with KOLs and clinical translational experts in medical, academic and regulatory communities.Minimum Requirements/Qualifications :
    • PhD 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 CD, UC fibrosis, fibrosis biomarkers research.
    • Recognized expertise in biomarker discovery and development and Translational Medicine documented by publications, regulatory submissions and/or national or international presentations.
    • Excellent understanding of drug development, regulatory processes and clinical development.What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementMore 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.Base Salary Range: $143,500.00 to $205,000.00, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.#LI-SGM#LI-HybridEEO 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.LocationsBoston, MASan Diego, CAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceuticals, San Diego , Associate Director, Translational Biomarker Lead, IBD - Entyvio, Executive , San Diego, California

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