Bioanalytical and Biomarker Logistics Manager

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JOB DESCRIPTION (Scientist I)

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Bioanalytical and Biomarker Logistics Manager in our Cambridge, MA or San Diego, CA office. 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. 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.

The Bioanalytical and Biomarker Logistics Manager is an exciting,high impact role within the Biomarker Science and Technologies (BST) department within Preclinical and Translational Sciences (PTS) at Takeda. You will work with stakeholders within BST, PTS, and with partners across the business including Clinical Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker operations and logistics with external vendors thereby helping create high quality clinical data.

POSITION ACCOUNTABILITIES

• TheBioanalytical and Biomarker Logistics Managerwill manage relationships with multiple external specialtytesting labs and bioassay vendors, biomarker specimen management and tracking, ensuring clinical sample testing and biomarker data management.
• Function as key contact with external laboratories, with oversight responsibilities for the developmentof agreements, statements of work, triggering of sample analyses, connecting the correct parties for data transfer specifications and data transfer agreements.
• Attends and participates in program and study level meetings with internal and external stakeholders
• Work with study teams to oversee work at specialty labs in regards to timelines, sample management, testing and data delivery
• Solicit and review Scope of Work documents and work with Procurement and other partners to produce contracts.
• Coordinate the bioanalytical and biomarker specimen strategy with appropriate stakeholders; observing the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP.
• Work with study teams to develop clinical sample management plans.
• Coordinate BST stakeholder review and contributions to clinical study protocols, informed consents and central laboratory documents to ensure quality and accuracy.
• Ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality.
• Plan, coordinate, and oversee all operational activities required to manage the lifecycle of bioanalytical and biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, trigger analysis, reconciliation of samples and data, and final sample disposition).
• Identify stakeholders for questions impacting clinical samples and escalate issues to provide a resolution.
• Use tracking systems such as Labmatrix to report progress, address issues and resolutions.
• Interface with data standards and data management teams to ensure biomarker data standards are defined for each readout in data transfer specification (DTS) and that approved controlled terminology is used within clinical study protocols.
• High level oversight of study and assay timelines, tracking of critical path activities, and risk/mitigation planning as needed to ensure successful data delivery and meet study timelines

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• BS, MS or PhD in Biochemistry, Biology, Medical Technology, Immunology, Pharmacy or related pharmaceutical sciences.
• PhD degree in a scientific discipline (or equivalent), or
  MS with 6+ years relevant experience, or BS with 8+ years relevant experience
• Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.
• Experience in sample management activities across multiple projects.
• Ability to work with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support study deliverables.
• Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors.
• 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.

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 Programs

Location and Salary Information:

• Location: Cambridge, MA or San Diego, CA
• Base Salary Range: $105,000 - $150,000 based on candidate professional experience level.
• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO 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.