Head of Biospecimen Management
Company: Sanofi
Location: Morristown
Posted on: June 30, 2025
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Job Description:
Job Title: Head of Biospecimen Management About the job:
Biospecimen Management is a global team and, within the
Translational Medicine Unit, part of Operations. The team is
responsible for sample collection, handling, and logistics of
samples that are collected for pharmacokinetic, immunogenicity, or
biomarker analyses in Sanofi's clinical trials. Main
Responsibilities: Leads a global team that supports all aspects of
sample management for clinical trials of all phases. Supports some
aspects of the management of pre-clinical biospecimens. Responsible
for the strategy of Biospecimen Management for biomarkers and
bioanalysis. Oversees the activities of the biospecimen management
team: Implementing the translational medicine strategy (e.g.,
Biomarker/Companion Diagnostics, pharmacokinetic, anti-drug
antibodies) of clinical trials, focusing on biospecimen operations.
Reviewing clinical trial protocols and Informed Consent Forms 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. Preparation of study-related
documents, e.g. Study Sample Management Plan. The entire business
process of biospecimen lifecycle, ensuring that samples are
collected, shipped, processed, analyzed, and stored with the
highest degree of quality and in compliance with applicable
regulations. Tracking and managing all sample related activities
for PK, PD, and biomarkers; supporting discrepancy resolution
between CL and BA laboratory. Setting up the analytical Laboratory
Information Management System software to register biospecimen of
clinical trials to be prepared for analysis. Registering of
samples, label preparation, correct storage, and compliant
destruction. Accountable for quality and compliance in the handling
of clinical samples; assures accuracy of sample delivery for
analysis. Supports the management of 'precious' samples and samples
for future use. Works with local teams to manage clinical samples
according to health authority guidelines and quality requirements
defined in GLP/GCP. Liaises with the clinical study organization,
bioanalytical experts, and external partners (e.g., CRO, analytical
labs) to ensure cross-functional alignment, and adherence to
deliverables and timelines. Develops productive working
relationships with central labs, ensuring the shipping, delivery,
and quality of biospecimen fulfil Sanofi expectations. About You
Master’s Degree in a biomedical science or related discipline and 5
plus years of people management experience in a pharmaceutical
environment. Practical experience in sample management Operational
experience in clinical studies Project management experience Hands
on experience with LIMS system, e.g. Watson Basic knowledge of data
management and process optimization through digitization and AI
applications Technical skills: Familiar with requirements of
regulatory authorities (GCP, GCLP, international guidance) Solid
understanding of the operational aspects of clinical trials
Knowledge of biomarkers, PK, ADA, and bioanalysis. Soft skills:
Excellent communication skills Mind set for high quality Respectful
of timelines Collaborative team worker All compensation will be
determined commensurate with demonstrated experience. Employees may
be eligible to participate in Company employee benefit programs,
and additional benefits information can be found here.
Keywords: Sanofi, West Orange , Head of Biospecimen Management, Science, Research & Development , Morristown, New Jersey
