Translational Medicine Operations Global Biospecimen Project & Team Leader

Job Title and Location Translational Medicine Operations Global Biospecimen Project & Team Leader – Cambridge, MA Overview 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, coordinating between Biospecimen Management and cross‑functional project/study teams to ensure that all biological sample collection, processing, storage, shipment, and tracking activities comply with study protocols, regulatory requirements, and Sanofi SOPs. The Lead will also function as a team leader for cross‑functional biospecimen initiatives while managing a team of biospecimen professionals. Main Responsibilities End to End Biospecimen Management 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, central labs, biomarker/Bioanalysis outsourcing, specialty labs, and biorepositories to ensure timely and compliant sample collection and processing. Monitor biospecimen data quality and completeness in LIMS and clinical data systems, resolving discrepancies in a timely manner. Track sample inventory, chain of custody, and 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. Project Leadership & Management 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. 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. Team Leadership & Development 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. Strategic Planning & Operations 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 optimization initiatives. Collaborate with senior leadership on strategic planning and resource allocation. Represent biospecimen management in cross‑functional leadership meetings. Stakeholder Management & Communication Serve as primary liaison between biospecimen operations and senior management. Present project status, metrics, and strategic recommendations to executive leadership. Manage relationships with external vendors, CROs, and laboratory partners. Coordinate with global regulatory teams on biospecimen compliance requirements. Quality & Compliance Oversight Ensure team compliance with GCP, GCLP, and applicable regulatory requirements. Oversee quality management systems and continuous improvement initiatives. Lead internal audits and support regulatory inspections. Ensure adherence to ethical standards and informed consent requirements. Drive implementation of corrective and preventive actions (CAPA). Maintain oversight of data integrity and specimen traceability. Budget & Resource Management Optimize resource utilization and cost‑effectiveness across projects. Negotiate contracts and service agreements with external partners. Justify resource requirements and proposals to senior leadership. About You Education Bachelor's degree in Life Sciences, Biology, Medical Technology, or related field (required). Master's degree in business administration (MBA), Project Management, or Life Sciences (preferred). Experience Minimum 9 years of experience in biospecimen management, clinical research, or laboratory operations. At least 5 years in project management and team leadership roles. Technical Skills Proven track record managing complex, multi‑site clinical trial biospecimen operations. Experience leading cross‑functional teams and managing matrix organizations. Deep expertise in biospecimen collection, processing, storage, and analysis methodologies. Comprehensive knowledge of regulatory requirements (GCP, GCLP, ICH, FDA, EMA). Experience with Laboratory Information Management Systems (LIMS) and specimen tracking platforms. Agile or Project Management certification (plus). Proficiency with project management tools (MS Project, Smartsheet, JIRA) (plus). Experience in pharmaceutical or biotechnology industry. Knowledge of precision medicine and companion diagnostics. Familiarity with biobanking best practices and ISBER guidelines. Experience with digital transformation and laboratory automation (plus). Experience with regulatory submissions and health authority interactions (plus). Global clinical trial experience across multiple regions. Preferred Qualifications Demonstrated success in budget management and resource optimization. Leadership experience in dynamic, fast‑paced environments. Leadership Competencies Exceptional leadership and team management capabilities. Strategic thinking with strong operational execution skills. Outstanding communication and presentation abilities. Proven ability to influence and drive change across organizations. Strong analytical and problem‑solving skills. Excellent stakeholder management and relationship‑building abilities. Cultural sensitivity and ability to lead global, diverse teams. Adaptability and resilience in dynamic, fast‑paced environments. Benefits Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact. Health and wellbeing benefits include high‑quality healthcare, prevention and wellness programs and at least 14 weeks of gender‑neutral parental leave. Salary The salary range for this position is: $122,250.00 – $176,583.33. All compensation will be determined commensurate with demonstrated experience. EEO Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiliated Ehrenberg Charged (sic) employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr Sanofi