Associate Director, Translational Biomarker Assays Analytical Lead

Company: Takeda Pharmaceutical
Location: Bonita
Posted on: November 25, 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 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, Translational Biomarker Assays Analytical Lead where you will provide leadership and oversight in the state-of-the-art biomarkers assay technologies, research planning and decision making in assigned Gastroenterology, Hepatology, Neurogastroenterology, and Motility disease projects in the preclinical and clinical stages. This is a highly visible and matrixed role, responsible for partnering with Gastro-Intestinal Drug Discovery Unit (GI DDU) Discovery Research scientists, Translational Biomarker Research leads, Physician Scientists, Biostatisticians, and Computational Biologists and work in Translational sub-teams. You will also be the subject matter expert, leveraging cutting-edge clinical assay technology and assay platforms for biochemical assays, cell-based assays, proteomics, LCMS, flow cytometry, etc. and oversee the development, validation and implementation of translational biomarker assays for clinical studies. As part of the GI DDU, you will report to the Senior Director, Translational Medicine & Biomarkers, Head of Translational Biomarker Research, and work with functional line leadership and Translational Biomarkers Research Leads to develop Translational biomarkers assay plans as part of the Asset Strategy through all stages of Research, clinical development, and post-market activities.How you will contribute:

• In partnership with functional line leadership, develop and implement a department-level strategy and approach to ensure that biomarker and companion diagnostics (CDx) assays for clinical endpoints and patient stratification/selection are validated for the Context of Use (CoU) and meet regulatory requirements.
• Partner with GI DDU Discovery Research Leads, Translational Biomarker Leads and Physician Scientists in defining and executing fit-for-purpose assays for pre-clinical translational studies in targeted pathways in the discovery research stages.
• As a subject-matter expert, collaborate across multiple sites and functional areas, working with Translational Biomarker Leads, Physician Scientists, Discovery Research scientists, Clinical Study Leads to provide well defined CoU for implementing the biomarkers assays supporting the translational medicine and biomarkers goals for progression of program from discovery research through clinical development and to support overall asset strategies.
• Oversee the biomarker assay development and execution to support the clinical stage portfolio, including the biomarker driven experimental medicine studies, incorporating biomarker-based endpoints for decision-making such as patient selection, surrogates of drug efficacy and biomarkers to understand drug mechanism of action and safety, and possible utilization as CDx.
• Establish strategic relationships with external laboratory partners/assay vendors and work in close collaboration with relevant line functions within Takeda to ensure clear communication of timelines to internal teams, and work closely with Translational Biomarkers Lead to drive the execution of clinical assays on time and with highest quality at the vendor, consistent with Global Program Team and senior management expectations.
• Work with Bioinformatics and Computational Biologists for data reporting and visualization platforms, ensuring high scientific quality.
• Support Translational Biomarkers Lead in the preparation and review of relevant sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies. Contribute to and ensure the quality of technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management.
• Participate in large academic/industry partnerships/consortia and leverage data from large biobanks (including UK Biobank; IBD-Plexus; Crohn's and Colitis Foundation; FNIH) to support GI-DDU programs.
• Establish and maintain scientific dialog with KOLs and relevant biomarkers assay experts in medical, academic, CRO's and regulatory communities.Minimum Requirements/Qualifications:
  • PhD or MD/PhD degree in relevant field with 8+ years of experience (job title is commensurate with experience).
  • At least 3 years of experience in clinical assay development, validation and implementation, with a track record of high impact in drug development research in cross-functional matrixed teams.
  • Experience in any combination of the following areas is required: flow cytometry, proteomics, LCMS, and biochemical and cell-based assays.
  • In-depth knowledge of regulatory requirement and CLIA/CAP guidelines for biomarker method validation, and best practice.
  • Recognized expertise in translational and clinical biomarkers research and development as demonstrated by publications, regulatory submissions and national or international presentations.
  • Excellent understanding of drug development, regulatory processes, and clinical development.
  • In-depth knowledge of clinical assay development and validation approaches and applications in drug development, good understanding of regulatory requirement and industry best practice, detailed literature and technology reviews, consultations with experts in multiple therapeutic areas, understanding of logistical and regulatory factors pertaining to clinical technologies.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 to $205,000, 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

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