Head of Biospecimen Management
Company: Sanofi
Location: Cambridge
Posted on: June 25, 2025
|
|
|
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, Nantucket , Head of Biospecimen Management, Science, Research & Development , Cambridge, Massachusetts
