Translational Medicine Operations Global Biospecimen Project & Team Leader
Sanofi
June 27, 2026
Remote friendly (Cambridge, MA)
United States
$122,250 - $176,583.33 USD yearly
Operations
Main Responsibilities
- Serve as Biospecimen manager/lead and primary biospecimen point of contact for assigned clinical studies.
- Review study protocols, lab manuals, and informed consent forms for biospecimen collection/handling.
- Develop and maintain study-specific biospecimen management plans (collection schedules, processing instructions, shipment logistics).
- Coordinate with clinical operations, clinical sites, central labs, specialty labs, biorepositories; represent biospecimen in audits.
- Monitor biospecimen data quality/completeness in LIMS and clinical data systems; resolve discrepancies.
- Track sample inventory, chain of custody, and sample accountability.
- Manage deviations/non-conformances; conduct root cause analysis and implement CAPA.
- Collaborate with biomarker scientists, translational medicine teams, and clinical operations.
- Ensure compliance with ICH/GCP and applicable regulations (e.g., IATA, CITES, import/export) and Sanofi SOPs; support study close-out.
- Train and guide team members on biospecimen collection/handling.
Project Leadership & Team Leadership
- Lead complex, multi-site biospecimen studies from initiation to completion; manage scope, deliverables, risks, and timelines.
- Develop project plans/resource allocation; coordinate global trial activities.
- Lead, mentor, and develop biospecimen professionals; manage workload, recruitment, onboarding, performance, and career development.
Strategic Operations, Stakeholders, Quality, Budget
- Implement strategies, KPIs, process improvements, and technology/system optimization.
- Present status/metrics to leadership; manage external vendors/CROs/lab partners.
- Oversee quality management, internal audits, regulatory inspections, data integrity, and specimen traceability.
- Optimize resources; negotiate service agreements; justify resource needs.
Qualifications
- Bachelor’s degree in Life Sciences/ Biology/ Medical Technology (or related) required.
- Master’s (MBA, Project Management, or Life Sciences) preferred.
- 9+ years in biospecimen management, clinical research, or lab operations.
- 5+ years in project management and team leadership roles.
Skills/Preferred
- Track record managing complex, multi-site clinical biospecimen operations.
- Cross-functional leadership/matrix experience.
- Deep expertise in collection, processing, storage, and analysis.
- GCP knowledge; LIMS and specimen tracking experience.
- Preferred: budget/resource optimization success; Agile/PM certification; MS Project/Smartsheet/JIRA; GCLP/ICH/FDA/EMA knowledge; pharma/biotech experience; precision medicine/companion diagnostics; biobanking/ISBER; digital transformation/automation; regulatory submissions/health authority interactions; global trial experience.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Serve as Biospecimen manager/lead and primary biospecimen point of contact for assigned clinical studies.
- Review study protocols, lab manuals, and informed consent forms for biospecimen collection/handling.
- Develop and maintain study-specific biospecimen management plans (collection schedules, processing instructions, shipment logistics).
- Coordinate with clinical operations, clinical sites, central labs, specialty labs, biorepositories; represent biospecimen in audits.
- Monitor biospecimen data quality/completeness in LIMS and clinical data systems; resolve discrepancies.
- Track sample inventory, chain of custody, and sample accountability.
- Manage deviations/non-conformances; conduct root cause analysis and implement CAPA.
- Collaborate with biomarker scientists, translational medicine teams, and clinical operations.
- Ensure compliance with ICH/GCP and applicable regulations (e.g., IATA, CITES, import/export) and Sanofi SOPs; support study close-out.
- Train and guide team members on biospecimen collection/handling.
Project Leadership & Team Leadership
- Lead complex, multi-site biospecimen studies from initiation to completion; manage scope, deliverables, risks, and timelines.
- Develop project plans/resource allocation; coordinate global trial activities.
- Lead, mentor, and develop biospecimen professionals; manage workload, recruitment, onboarding, performance, and career development.
Strategic Operations, Stakeholders, Quality, Budget
- Implement strategies, KPIs, process improvements, and technology/system optimization.
- Present status/metrics to leadership; manage external vendors/CROs/lab partners.
- Oversee quality management, internal audits, regulatory inspections, data integrity, and specimen traceability.
- Optimize resources; negotiate service agreements; justify resource needs.
Qualifications
- Bachelor’s degree in Life Sciences/ Biology/ Medical Technology (or related) required.
- Master’s (MBA, Project Management, or Life Sciences) preferred.
- 9+ years in biospecimen management, clinical research, or lab operations.
- 5+ years in project management and team leadership roles.
Skills/Preferred
- Track record managing complex, multi-site clinical biospecimen operations.
- Cross-functional leadership/matrix experience.
- Deep expertise in collection, processing, storage, and analysis.
- GCP knowledge; LIMS and specimen tracking experience.
- Preferred: budget/resource optimization success; Agile/PM certification; MS Project/Smartsheet/JIRA; GCLP/ICH/FDA/EMA knowledge; pharma/biotech experience; precision medicine/companion diagnostics; biobanking/ISBER; digital transformation/automation; regulatory submissions/health authority interactions; global trial experience.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.