Translational Medicine Operations Global Biospecimen Project & Team Leader - all genders

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. This person will serve as the primary biospecimen point of contact for the Project or study team, acts 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 Global Biospecimen Management Project Lead will also function as team leader for cross-functional biospecimen management initiatives while managing a team of biospecimen professionals. This role combines strategic project leadership with operational team management to ensure successful delivery of biospecimen objectives across multiple clinical studies and research programs. The position requires expertise in both project management methodologies and biospecimen operations to drive excellence in sample collection, processing, and utilization.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives

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

Act as a consult with clinical operations that coordinate with clinical sites, central labs and with the 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 (Biospecimen managers/ Lab coordinators)

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 10-12 years of experience in biospecimen management, clinical research, or laboratory operations

At least 5-7 years in project management and team leadership roles

Proven track record managing complex, multi-site clinical trial biospecimen operations

Experience leading cross-functional teams and managing matrix organizations

Demonstrated success in budget management and resource optimization

Certifications & Technical Skills

Agile or Project Management certification is a plus

Deep expertise in biospecimen collection, processing, storage, and analysis methodologies

Comprehensive knowledge of regulatory requirements (GCP, GCLP, ICH, FDA, EMA)

Proficiency with project management tools (MS Project, Smartsheet, JIRA) is a plus

Experience with Laboratory Information Management Systems (LIMS) and specimen tracking platforms

Understanding of biomarker development and translational research applications

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

Preferred Qualifications

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

Key Performance Indicators

Project delivery success rate (on-time, on-budget, quality metrics)

Team performance and engagement scores

Biospecimen quality metrics and compliance rates

Cost optimization and budget adherence

Stakeholder satisfaction ratings

Process improvement implementation and impact

Team development and growth

Working Conditions

Office and laboratory environment with occasional field visits

Flexibility to support global operations across multiple time zones

May require extended hours during critical project phases

Hybrid work arrangement based on local Sanofi site procedures

Language

Fluency in English

Why choose us:

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Benefit from a well-thought-out benefits package that rewards your contribution and commitment.

We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.

Your role in Biospecimen Management is foundational to Translational Medicine Operations success. Translational Medicine provides the biological foundation upon which all translational insights are built. The quality, accessibility, and strategic management of the biological samples directly impacts our ability to transform promising research into life-changing medicines for patients.

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€83,856.00 - €125,784.00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.