Translational Medicine Operations Global Biospecimen Project & Team Leader

Translational Medicine Operations Global Biospecimen Project & Team Leader Location: Cambridge, MA About the Job 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. Main Responsibilities End to End Biospecimen Management 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. 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. 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. 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. Minimum 9 years of experience in biospecimen management, clinical research, or laboratory operations. At least 5 years in project management and team leadership roles. Experience & 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). Experience with Laboratory Information Management Systems (LIMS) and specimen tracking platforms. Preferred Qualifications Demonstrated success in budget management and resource optimization. Agile or Project Management certification is a plus. Proficiency with project management tools (MS Project, Smartsheet, JIRA) is a plus. Comprehensive knowledge of regulatory requirements (GCLP, ICH, FDA, EMA). 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 is a plus. Experience with regulatory submissions and health authority interactions is a plus. Global clinical trial experience across multiple regions. 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. Compensation & Benefits The salary range for this position is: $122,250.00 - $176,583.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union 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, or any other characteristic protected by law. #J-18808-Ljbffr Mass Digital Health