Translational Medicine Operations Global Biospecimen Project & Team Leader

Translational Medicine Operations Global Biospecimen Project & Team Leader

Location:

Cambridge, MA

The Global Biospecimen Management Project and Team Lead will be responsible for the end‑to‑end operational oversight of biospecimen activities for assigned clinical studies. The role serves as the primary biospecimen point of contact for the project or study team, acting as a key liaison between Biospecimen Management and cross‑functional project/study teams, ensuring that all biological sample collection, processing, storage, shipment, and tracking activities are executed in compliance with study protocols, regulatory requirements, and Sanofi SOPs.

The position also functions as team leader for cross‑functional biospecimen management initiatives while managing a team of biospecimen professionals. It combines strategic project leadership with operational team management to ensure successful delivery of biospecimen objectives across multiple clinical studies and research programs.

• Act as a biospecimen manager/lead and serve as the dedicated biospecimen subject matter expert for assigned clinical studies or multiple studies within a project or indication.
• Review and provide input on study protocols, lab manuals, and informed consent forms related to biospecimen collection and handling.
• Develop and maintain study‑specific biospecimen management plans, including collection schedules, processing instructions, and shipment logistics.
• Consult with clinical operations that coordinate with clinical sites, central labs, Biomarkers/Bioanalysis outsourcing for specialty labs, and biorepositories to ensure timely and compliant sample collection and processing and in audits as the biospecimen representative.
• Monitor biospecimen data quality and completeness in LIMS and clinical data systems; resolve discrepancies in a timely manner.
• Track sample inventory, chain of custody, and sample accountability throughout the study lifecycle.
• Manage sample deviations and non‑conformances; conduct root cause analysis and implement corrective actions.
• Collaborate with biomarker scientists, translational medicine teams, and clinical operations to align biospecimen activities with scientific objectives.
• Ensure compliance with ICH/GCP guidelines, applicable regulations (e.g., IATA, CITES, import/export requirements), and Sanofi policies.
• Contribute to study close‑out activities including final sample reconciliation and archival.
• Provide training and guidance to new team members on biospecimen collection and handling procedures.

• Lead complex, multi‑site biospecimen management studies/projects from initiation through completion.
• Develop comprehensive project plans, timelines, and resource allocation strategies.
• Manage project scope, deliverables, and stakeholder expectations across clinical development programs.
• Coordinate biospecimen activities across global clinical trials and research studies.
• Identify and mitigate project risks, implementing contingency plans as needed.
• Ensure projects are delivered on time and meet quality standards.
• Facilitate cross‑functional collaboration between Clinical Operations, Laboratory Sciences, Regulatory Affairs, and Data Management teams.

• Lead, mentor, and develop a team of biospecimen management professionals.
• Provide strategic direction and operational guidance to team members.
• Conduct performance evaluations, career development planning, and succession planning.
• Foster a culture of scientific excellence, quality, and continuous improvement.
• Manage team workload distribution and resource allocation across multiple projects.
• Lead recruitment, onboarding, and training of new team members.
• Promote professional development through training opportunities and industry engagement.

• Implement biospecimen management strategies aligned with organizational objectives.
• Establish and monitor key performance indicators (KPIs) and operational metrics.
• Drive process improvements and standardization across biospecimen operations.
• Lead technology implementation and system…