Senior Scientist - Sample Management and Biobank
Takeda
17 days ago
Remote
United States
$137,000 - $215,270 USD yearly
Operations
Objective/Purpose
- Enterprise partner responsible for planning, coordinating, and overseeing logistical activities to manage the lifecycle of bioanalytical and biomarker samples (including sample metadata) for Takeda clinical studies.
Responsibilities
- Coordinate bioanalytical/biomarker specimen strategy across clinical programs while meeting quality, ethical, and regulatory standards (ICH/GDPR/GCP/GLP).
- Develop and review clinical sample management plans; contribute to protocols, informed consents, and central lab documents.
- Ensure Clinical Lab Manual procedures cover collection, processing, and shipping; standardize/harmonize biospecimen activities across studies.
- Plan and coordinate sample lifecycle activities: collection, shipping, processing, analysis support, reconciliation, and final sample disposition.
- Manage study-level biomarker tracking with Translational, Clinical, CRO, and central lab stakeholders; maintain chain-of-custody and high-quality, inventoried samples.
- Coordinate end-of-study sample fate decisions (consent and translational value considerations).
- Oversee logistics with central/testing labs and long-term storage partners; generate tracking/reconciliation reports.
- Develop training materials (SOPs, job aids, flow charts); maintain trackers/spreadsheets.
- Manage FSP resources and lead small teams; handle MSAs/SOWs/MTAs reviews and budget/financial systems for sample management.
Qualifications
- PhD (3+ years) or MS (9+ years) or BS (11+ years) in a scientific discipline.
Skills/Competencies (Required/Preferred)
- Drug development/clinical study knowledge; sample + sample metadata management across multiple phases.
- Working knowledge of FDA and ICH/GCP and clinical laboratory specimen handling (other regions a plus).
- Experience with sample management platforms.
- Analytical methods/fit-for-purpose assay rigor (qualification/validation) knowledge.
- Critical reasoning, leadership, and effective cross-functional communication.
Benefits (explicit)
- U.S. base salary range: $137,000–$215,270; may include incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time).
- Enterprise partner responsible for planning, coordinating, and overseeing logistical activities to manage the lifecycle of bioanalytical and biomarker samples (including sample metadata) for Takeda clinical studies.
Responsibilities
- Coordinate bioanalytical/biomarker specimen strategy across clinical programs while meeting quality, ethical, and regulatory standards (ICH/GDPR/GCP/GLP).
- Develop and review clinical sample management plans; contribute to protocols, informed consents, and central lab documents.
- Ensure Clinical Lab Manual procedures cover collection, processing, and shipping; standardize/harmonize biospecimen activities across studies.
- Plan and coordinate sample lifecycle activities: collection, shipping, processing, analysis support, reconciliation, and final sample disposition.
- Manage study-level biomarker tracking with Translational, Clinical, CRO, and central lab stakeholders; maintain chain-of-custody and high-quality, inventoried samples.
- Coordinate end-of-study sample fate decisions (consent and translational value considerations).
- Oversee logistics with central/testing labs and long-term storage partners; generate tracking/reconciliation reports.
- Develop training materials (SOPs, job aids, flow charts); maintain trackers/spreadsheets.
- Manage FSP resources and lead small teams; handle MSAs/SOWs/MTAs reviews and budget/financial systems for sample management.
Qualifications
- PhD (3+ years) or MS (9+ years) or BS (11+ years) in a scientific discipline.
Skills/Competencies (Required/Preferred)
- Drug development/clinical study knowledge; sample + sample metadata management across multiple phases.
- Working knowledge of FDA and ICH/GCP and clinical laboratory specimen handling (other regions a plus).
- Experience with sample management platforms.
- Analytical methods/fit-for-purpose assay rigor (qualification/validation) knowledge.
- Critical reasoning, leadership, and effective cross-functional communication.
Benefits (explicit)
- U.S. base salary range: $137,000–$215,270; may include incentives and benefits (medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time).