Senior Scientist - Sample Management and Biobank
Takeda
19 days ago
Remote
United States
$137,000 - $215,270 USD yearly
Operations
Objective / Purpose:
Enterprise level partner responsible for planning, coordinating, and overseeing logistical activities to manage the lifecycle of bioanalytical and biomarker samples supporting Takeda clinical studies. Works cross-functionally with translational teams, therapeutic areas, clinical operations, and clinical data management, and with central laboratories, testing labs, and long-term storage partners to track samples and sample metadata, maintain chain-of-custody, ensure quality, and enable high-quality bioanalytical/biomarker data.
Responsibilities:
- Partner across Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance, and Quality Assurance.
- Coordinate bioanalytical/biomarker specimen strategy across clinical programs meeting ICH/GDPR/GCP/GLP quality and regulatory standards.
- Develop clinical sample management plans; review/contribute to protocols, informed consents, and central laboratory documents.
- Ensure specimen handling/processing steps are described in Clinical Lab Manuals; standardize/harmonize end-to-end biospecimen activities; maximize accrual and quality.
- Support sample lifecycle activities (collection, shipping, processing, analysis, final disposition) and study-level tracking/management in collaboration with CROs and laboratories.
- Oversee logistics (site collection, vendor shipment for testing/processing, reconciliation, final disposition) and end-of-study sample fate decisions.
- Manage vendor/partner relationships; support inventory management and sample tracking/reconciliation reporting.
- Develop training/enablement materials (SOPs, job aids, flow charts); maintain sample-management trackers/forms.
- Experience managing FSP resources and leading small teams; support contracts (MSA/SOW/MTAs) reviews and relevant budgeting/financial systems.
Education & Qualifications:
- PhD (3+ years) or MS (9+ years) or BS (11+ years) in a scientific discipline.
Desired Technical Skills:
- Drug development/clinical study knowledge; role of bioanalysis/biomarkers.
- Experience in sample (and sample metadata) management across sample lifecycle.
- Knowledge of FDA & ICH/GCP; familiarity with other regions a plus.
- Experience with sample management platforms.
- Critical reasoning to resolve complex problems; ability to lead small teams and work in multidisciplinary teams.
Desired Behavioral Skills:
- Strong written, organizational, leadership, and interpersonal communication.
- Works under pressure and tight timelines; self-motivated, independent, organized, detail-oriented.
Enterprise level partner responsible for planning, coordinating, and overseeing logistical activities to manage the lifecycle of bioanalytical and biomarker samples supporting Takeda clinical studies. Works cross-functionally with translational teams, therapeutic areas, clinical operations, and clinical data management, and with central laboratories, testing labs, and long-term storage partners to track samples and sample metadata, maintain chain-of-custody, ensure quality, and enable high-quality bioanalytical/biomarker data.
Responsibilities:
- Partner across Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance, and Quality Assurance.
- Coordinate bioanalytical/biomarker specimen strategy across clinical programs meeting ICH/GDPR/GCP/GLP quality and regulatory standards.
- Develop clinical sample management plans; review/contribute to protocols, informed consents, and central laboratory documents.
- Ensure specimen handling/processing steps are described in Clinical Lab Manuals; standardize/harmonize end-to-end biospecimen activities; maximize accrual and quality.
- Support sample lifecycle activities (collection, shipping, processing, analysis, final disposition) and study-level tracking/management in collaboration with CROs and laboratories.
- Oversee logistics (site collection, vendor shipment for testing/processing, reconciliation, final disposition) and end-of-study sample fate decisions.
- Manage vendor/partner relationships; support inventory management and sample tracking/reconciliation reporting.
- Develop training/enablement materials (SOPs, job aids, flow charts); maintain sample-management trackers/forms.
- Experience managing FSP resources and leading small teams; support contracts (MSA/SOW/MTAs) reviews and relevant budgeting/financial systems.
Education & Qualifications:
- PhD (3+ years) or MS (9+ years) or BS (11+ years) in a scientific discipline.
Desired Technical Skills:
- Drug development/clinical study knowledge; role of bioanalysis/biomarkers.
- Experience in sample (and sample metadata) management across sample lifecycle.
- Knowledge of FDA & ICH/GCP; familiarity with other regions a plus.
- Experience with sample management platforms.
- Critical reasoning to resolve complex problems; ability to lead small teams and work in multidisciplinary teams.
Desired Behavioral Skills:
- Strong written, organizational, leadership, and interpersonal communication.
- Works under pressure and tight timelines; self-motivated, independent, organized, detail-oriented.