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Senior / Principal Scientist, CBID Gastroenterology

Company: Takeda Pharmaceutical
Location: Arlington
Posted on: November 19, 2021

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 Senior / Principal Scientist, CBID GastroenterologyAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior / Principal Scientist, CBID Gastroenterologyin our Cambridge, MA 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.As a Senior / Principal Scientist, CBID Gastroenterology working on the Clinical Biomarkers team, you will be empowered to provide technical and scientific leadership as the CBID program lead, harmonize the activities within CBID group and collaborate with larger program/clinical team to assure the clinical biomarker assay and data deliveryA typical day will include:POSITION OBJECTIVES:

  • Contribute to the clinical development of novel therapeutics in Gastrointestinal area from pre-IND to Phase I-III clinical trials through developing and executing clinical biomarker strategies. Strong focus in IBD, Neuro-gastroenterology & Motility, Intestinal fibrosis, Liver fibrosis or Gut-liver axis. is a plus.
  • Provide technical and scientific leadership as the CBID program lead, harmonize the activities within CBID group and collaborate with larger program/clinical team to assure the clinical biomarker assay and data delivery
  • Conduct biomarker assay development across different technologies and disease area within GI, including cutting edge technology assessment, applying validation process to meet fit-for-purpose assay development, understanding and troubleshooting the technical, regulatory and logistic aspectsPOSITION ACCOUNTABILITIES:
    • As a CBID program lead, participate in the key program team meetings (clinical and translational subteams), communicate with the team for key activities, deliverables and timelines updates to the CBID subteam
    • CBID lead conducts a CBID subteam meeting to organize and harmonize the activities to support the program. CBID subteam will include bioanalytical lead(s) for PK and immunogenicity, scientific manager for contracts and sample logistics, and SME(s) for specific biomarker assay development if needed
    • Contribute to the development and implementation of clinical biomarker strategies by interfacing with GI DDU translational scientists and GI TAU clinicians; represent as a CBID at internal scientific meetings and external forums
    • Review and ensure alignment of clinical documents with the biomarker plan, e.g. clinical protocol, Informed Consent Form and contribute to Laboratory Manual, Investigators-- Brochure, etc, as needed.
    • Initiate technology/vendor selection, plan fit-for-purpose assay validation, oversee and review the validation process and report to ensure that the report meets regulatory requirement
    • Manage vendor labs responsible for the development and validation of clinical biomarker assays and monitor the performance of the biomarker assay during clinical study conduct.
    • Collaborate with clin ops and CRO labs to ensure the high quality data delivery
    • Collaborate with translational medicine scientist, computational scientists and statisticians to perform data mining and interpretation Lead the establishment and development of CDx platform by managing external vendors for timely delivery of high-quality clinical data within the required clinical study timelines when applicable
    • Develop/build upon disease-based knowledge for key indications of interest in GI, i.e. biology of disease, clinical treatment paradigms, current competitive landscape, and current/emerging biomarkers.
    • Build relationships and collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.
    • Success in this role will be evaluated by the ability to influence and inspire scientists in the organization, and to maintain a culture that encourages innovation, scientific rigor, and collaboration.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
      • PhD, MD, or MD/PhD in biology, pharmacology, or related discipline with at least 8 years of past post-doctoral experience, including at least 3 years in the drug development in industry is required for principal scientist
      • Strong knowledge and experience in inflammatory bowel disease and/or liver fibrosis,
      • Strong understanding and experience in drug development, especially designing and strategize clinical biomarker in early clinical development
      • Strong knowledge in regulatory requirements for clinical biomarker assays
      • A track record of sustained, significant scientific contributions as demonstrated by publications, patents, and presentations is required.
      • Strong scientific background and experience with assay development and validation in multiple technology platforms, especially those that are implementable in the clinical studies.
      • Experience with clinical trial and/or patient samples, especially with in gastroenterology is strongly desired.
      • Capable of applying the highest scientific and technical standards for the successful design and execution of clinical assays implemented from early to late-stage clinical programs.
      • Familiarity with clinical documents and processes, i.e. clinical protocols, informed consent forms, laboratory manuals, central lab logistics, etc. Takeda U.S. Vaccine Requirement: Absent 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. This job posting exclude Colorado applicants. TRAVEL REQUIREMENTS:
        • 5-10% primarily USWHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Arlington , Senior / Principal Scientist, CBID Gastroenterology, Healthcare , Arlington, Massachusetts

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