Senior Scientist - Sample Management and Biobank

📋 Description

• • Oversee the end-to-end lifecycle management of bioanalytical and biomarker samples across Takeda’s clinical studies, including collection, shipping, processing, analysis, reconciliation, and final disposition.
• • Coordinate sample management strategies across multiple clinical programs while ensuring compliance with quality, ethical, and regulatory standards including ICH, GDPR, GCP, and GLP.
• • Collaborate with Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance, and Quality Assurance teams to build strategic relationships and align sample management practices with study objectives.
• • Develop and review clinical sample management plans, study protocols, informed consents, and central laboratory documents to ensure accuracy, consistency, and regulatory compliance.
• • Ensure standardized and harmonized biospecimen handling procedures are documented in Clinical Lab Manuals for collection, processing, and shipping of clinical samples.
• • Support biomarker specimen tracking and management at the study level in partnership with Translational Teams, Clinical Study Teams, CROs, and Central Laboratories.
• • Manage relationships with central laboratories, testing vendors, and long-term storage partners to maintain chain-of-custody, sample integrity, and high-quality data generation.
• • Lead the planning and execution of end-of-study sample fate decisions, incorporating consent requirements and translational value assessments.
• • Develop and maintain SOPs, job aids, flowcharts, spreadsheets, trackers, and educational materials to standardize sample management processes and enable team training.
• • Utilize sample management platforms to track specimen data, generate reconciliation reports, and ensure accurate inventory management throughout the sample lifecycle.
• • Review and contribute to contracts, MSA, SOW, and MTA submissions related to sample management activities and associated budgets.
• • Lead small teams and manage FSP (Functional Service Provider) resources to execute sample management initiatives effectively.
• • Apply working knowledge of analytical methods, fit-for-purpose assay qualification, and validation requirements to support clinical study endpoints.
• • Demonstrate critical reasoning to identify and resolve complex logistical and regulatory challenges in sample management across global clinical trials.
• • Maintain high levels of organization, attention to detail, and independence while operating under tight timelines and high-pressure environments.
• • Communicate effectively across diverse functional areas with strong written, interpersonal, and leadership skills to interface with internal stakeholders and external vendors.