Associate Director, Translational Biomarker Lead, Liver Diseases

Company: Takeda Pharmaceutical
Location: Santee
Posted on: May 14, 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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Translational Biomarker Lead, Liver Diseases in our Cambridge, MA or San Diego, CA offices.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 NASH, liver fibrosis and other liver diseases 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 Hepatology and 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.
• 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 liver fibrosis, other liver diseases 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 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:
              • Requires approximately 15 - 25% travel.
              • Some international travel may be required.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: NASH, liver fibrosis, and/or other liver 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 ProgramsAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.This job posting excludes CO applicants.#LI-KL1EEO 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

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