Biomarker Sample Manager - Oncology

Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 11, 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?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.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. -JOB DESCRIPTIONAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a -Biomarker Sample Manager in our -Cambridge, MA -office.Takeda is committed to outsmarting cancer so that more patients may have access to our transformational medicines - a robust precision and translational medicine approach thoughtfully and strategically applied in drug development is of critical importance to achieve this important objective of our Oncology drug development organization. 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.The Clinical Biomarker Sample Manager is an exciting, high visibility, high impact role in the Clinical Biomarker Operations Team within Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda. The desired candidate will work with stakeholders within PTM and cross-functionally with partners in Clinical Pharmacology, Clinical Biomarker Innovation and Development, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical biomarker sample management and logistics with external vendors thereby helping generate high quality Translational biomarker data. -POSITION ACCOUNTABILITIESClinical Biomarker Sample Manager is responsible for the life cycle management of clinical bioanalytical (PK, ADA) and biomarker samples, and maintain sample chain-of-custody in a GxP-compliant setting. - Responsibilities include:

• Support the planning and coordination of clinical sample activities required to manage the lifecycle of biospecimen samples (e.g., collection, shipping, processing, analysis, data delivery and cleaning, and final sample disposition).
• Responsible for the development of Biomarker Sample Management Plans.
• Implement sample tracking systems/databases for new studies. - Provide centralized support to Takeda sample tracking systems/databases.
• Support Biomarker Operations Leads with biomarker sample tracking and management at study level, in close collaboration with the Translational Team, Clinical Study Team, CRO and Central Laboratory.
• Support Biomarker Operations Leads with resolution of biosample related data reconciliation and sample related issues at sites or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and Clinical Biomarker team.
• Drive a harmonized process to support each study team to deliver raw bioanalytical and biomarker data to meet study level timelines and milestone deliverables (e.g. Interim Analysis, Database Lock).
• Assist Biomarker Operations Leads to ensure that samples are used and/or stored appropriately per the associated Informed Consent.
• Support inventory reviews and work with the appropriate stakeholders to obtain approvals for disposal/transfer of samples in long-term storage facilities.
• Support biobanking related logistical and operational activities.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
  • BS, MS or PhD in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy, or related pharmaceutical sciences.
  • BS (8+), MS (5+) and PhD (2+) years of relevant work experience in drug development, sample/biospecimen management or clinical trial project management.
  • Knowledge of clinical trials and understanding of the role of biomarkers in clinical studies a plus.
  • Ability to oversee sample management activities across multiple projects.
  • Demonstrated ability to collaborate with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy.
  • Excellent written, organizational, and interpersonal communications skills to update the stakeholders and internal team members efficiently and succinctly on progress, address questions and issues as well as interface with external vendors.
  • Strong attention to detail, timelines and accuracy.
  • Works successfully under pressure with tight timelines.
  • Works effectively in a dynamic operational environment with cross functional stakeholders.
  • Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g. China and Brazil) a plus.
  • Experience with Labmatrix or equivalent sample management software is a plus.
  • Proven critical reasoning skills including the identification and resolution of complex problems.
  • Eager to grow and develop capabilities.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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-JT1EEO 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, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Malden , Biomarker Sample Manager - Oncology, Executive , Malden, Massachusetts