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

Role Overview

The Global Biospecimen Management Project and Team Lead will provide end-to-end operational oversight of biospecimen activities for assigned clinical studies.

The role serves as the primary biospecimen point of contact for study teams, liaising between biospecimen management and cross‑functional project/study teams to ensure compliant sample collection, processing, storage, shipment, and tracking in line with study protocols, regulatory requirements, and Sanofi SOPs.

This position blends strategic project leadership with operational team management to deliver biospecimen objectives across multiple clinical studies and research programs.

• Main Responsibilities
• End‑to‑End Biospecimen Management – act as the dedicated biospecimen subject‑matter expert, review protocols, develop management plans, consult with clinical operations, ensure data quality, manage inventory and deviations, and provide training to new team members.
• Project Leadership & Management – lead complex, multi‑site studies from initiation through completion, develop project plans, manage scope and stakeholder expectations, mitigate risks, and deliver projects on time and within quality standards.
• Team Leadership & Development – mentor and develop biospecimen managers and lab coordinators, conduct performance evaluations, plan career development, allocate workload, recruit and onboard new team members, and promote professional growth.
• Strategic Planning & Operations – implement biospecimen strategies aligned with organizational objectives, monitor KPIs, drive process improvements, lead technology implementation, and represent biospecimen management in cross‑functional leadership meetings.
• Stakeholder Management & Communication – serve as liaison between biospecimen operations and senior management, present project status and metrics, manage relationships with vendors, CROs, and laboratory partners, and coordinate with global regulatory teams.
• Quality & Compliance Oversight – ensure compliance with GCP, GCLP, and regulatory requirements, oversee quality management systems, lead internal audits, support regulatory inspections, implement CAPA, and maintain data integrity and specimen traceability.
• Budget & Resource Management – optimize resource utilization and cost‑effectiveness, negotiate contracts, justify resource requirements, and manage cost and budget adherence.

Qualifications

• Education – Bachelor’s degree in Life Sciences, Biology, Medical Technology, or related field required; Master’s degree in business administration, project management, or Life Sciences preferred.
• Experience – 10‑12 years in biospecimen management, clinical research, or laboratory operations with 5‑7 years in project management and team leadership roles.

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

• Certifications – Agile or Project Management certification is a plus.
• Technical Skills – 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); experience with LIMS and specimen tracking platforms; understanding of biomarker development and translational research.
• Leadership Competencies – exceptional team management, strategic thinking, strong communication and presentation abilities, influence and change management, analytical and problem‑solving skills, stakeholder management, cultural sensitivity, and resilience in dynamic environments.
• Preferred Qualifications
• Experience within the pharmaceutical or biotechnology industry and knowledge of precision medicine and companion diagnostics.
• Familiarity with biobanking best practices, ISBER guidelines, digital transformation, laboratory automation, regulatory submissions, and health authority interactions.
• 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 and process improvement impact.
• Working Conditions

Office and laboratory environment with occasional field visits.

Flexibility to support global operations across multiple time zones and hybrid work arrangement as per local Sanofi site procedures.

Language

Fluency in English.

Benefits

Competitive salary range: €83,856.00 – €125,784.00 (final compensation based on experience, skills, location, and other factors).

Health and social benefits include high‑quality healthcare coverage, prevention programs, long‑term illness coverage, 14‑week paid family leave for both parents, and a range of childcare benefits.

EEO Statement

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

Our company practices and policies are designed to ensure an inclusive and supportive work environment for all talent.

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