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Job Description

About 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 a Research Senior Scientist in Cambridge, MA, where you will act as an enterprise level partner responsible for the lifecycle management of clinical bioanalytical (PK, ADA) and biomarker samples, data, and specialty lab vendors to maintain chain-of-custody in a GxP-compliant setting.  You will serve as a conduit to the broader organization to help develop a framework, best practices, and efficiencies to drive standardization and simplification to enable connection of the translational strategy with operational planning and execution.  

As part of the Biomarker Science & Technologies (BST) group at Takeda, you will report to the Head of Sample and Data Operations, Director and you will will work to advance the mission of BST and its contributions to the clinical program lifecycle.

How you will contribute:                        

• 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).
• Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality.
• Develop robust processes to facilitate the planning, coordination, and oversight of all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition).
• Helps to develop best practices for resolution of biosample related data reconciliation and sample related activities (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition) in collaboration with relevant stakeholders including Data Management, Clinical Operations and Quality Assurance. 
• Utilize sample and data management automated tools to help define the process for data reconciliation of clinical biomarker samples and datasets to ensure adherence to the clinical study protocol, patient consent and data transfer specifications.
• Collaborate with Clinical Operations, clinical CRO, specialty and central laboratories to resolve sample and data reconciliation issues in a timely manner and maximize the quality of translational biomarker data.
• Collaborate with all team functions to design and operationalize a seamless process spanning from vendor onboarding, sample tracking and analysis, to data delivery and management.
• Work with the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/IVDR/GLP. 
• Responsible for developing and maintaining metrics for specialty lab vendor management at the partnership level, as well as overseeing escalations, governance).
• Help to maintain MSAs, legal agreements, and contracts related to BST activities, specialty labs, and p