Biosample Manager - VIE Contract (W/M/D)

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission:

Biosample Manager - VIE Contract (W/M/D)

Target start date: 01/07/2024

Our team is part of the Translational Medicine and Early Development Department of R&D at Sanofi.

As Biosample Manager you are responsible for the Biosample operational execution of the precision medicine strategy (e.g. Biomarker/CDx, pharmacokinetic (PK), anti-drug antibodies (ADA), anti-drug conjugates (ADC)) of clinical trials phase 1 - 3. In doing so, you are a key partner and interact with internal stakeholders (e.g., Precision medicine, Bioanalytic and pharmacokinetics experts, clinical operations, and clinical pharmacology) as well as external stakeholders (e.g., Central Labs and CROs) and member of the clinical trial team.

Your responsibilities:

• Implementing the translational medicine strategy (e.g., Biomarker/ Companion Diagnostics (CDx), pharmacokinetic (PK), anti-drug antibodies (ADA) of clinical trials, specifically focusing on Biosample operations.
• Overseeing the entire business process of Biosample lifecycle, ensuring that samples are collected, processed, analyzed, and stored with the highest degree of quality and in compliance with applicable regulations.
• Serving as the main point of contact for all operational aspects related to Biomarker/PK/ADA samples within the Clinical trial.
• Setting up the analytical Laboratory Information Management System (LIMS) software to register biosamples of clinical trials to be prepared for analysis.
• Acting as a liaison between the clinical teams, bioanalytical experts, and external partners (e.g., CRO, Analytical Labs) to ensure proper planning, cross-functional alignment, and adherence to deliverables and timelines.
• Reviewing clinical trial protocols and Informed Consent Forms (ICFs) to ensure that the collection and analysis of biological samples are conducted according to the protocol and the biomarker plan and in alignment with regulatory guidance.
• Overseeing Central Lab activities and contributing by writing the Sample Management Plans or reviewing documents (e.g., Central Laboratory documents) and materials (e.g., kit contents) to ensure proper biosample handling.
• Overseeing central lab activities, including the shipping of biosamples from Central Labs to assay laboratories, to ensure timely delivery and optimal analyzable quality.
• Maintaining oversight of all biosample operational activities and reporting on their status including sample collection and quality, and supporting sample reconciliation activities.

Requirements:

• Master degree, preferably in a scientific discipline or medical-related field such as Pharmacy / Biology / Chemistry.
• Good knowledge in MS Office.
• Demonstrated "get-things-done" mindset.
• Comfortable working with cross-functional teams consisting of a different mix of stakeholders, including, through an adaptive communication style.
• Basic knowledge of bio analytics and various bioanalytical methods.
• Fluent English is mandatory, knowledge of German would be a plus.

Pursueprogress. Discoverextraordinary.

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.