Biosample Management Team Leader

Job Title: Biosample Management Team Leader

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Biospecimen Management team oversees the 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., including activities of collection, delivery, and assay of biosamples.

The Biosample Managers delegates tasks, establishes workflows and timelines for analytical needs to support corporate goals and to ensure biosample process consistency across all clinical studies within their respective projects and manages sample logistics from patient to data.  The Biospecimen Management team collaborates with Translational Medicine Leads, Bioanalytical Experts and other stakeholders (e.g. CSO) of all levels to ensure sample management consistency and appropriate delivery and completion of tasks.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

A team leader supervises the group of employees. The Team leader motivates and inspires the team by creating an environment that promotes positive communication, encourages bonding of team members, and demonstrates flexibility. She/he will work with the teams to manage clinical samples according to regulated environment and quality requirements defined in GLP, GCLP

• Oversee day-to-day operation and monitor team performance and report on metrics.

• 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 (ICF) 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 (sample tracking) including sample collection and quality, and supporting sample reconciliation activities

• Create an inspiring team environment with an open communication culture

• Liaises with translational and pharmacokinetic scientists and clinical teams to establish analysis needs with clinical feasibility

• Collaborates with business partners and stakeholders on demands and expectations for all functions involved in the project

• Establish productive working relationships with sites, vendors, business partners, and other stakeholders

About You

Expected educational qualifications:

• Master’s degree or University degree – medical or paramedical (pharmacy, Biology, veterinary, etc.) or equivalent by experience

Expected experience:

• Minimum 5 years of experience in similar position or position and experiences working regulated (e.g., GLP, GCP, GCLP)

• Expertise in laboratory information management systems (e.g. Watson LIMS).

• Requires project management skills in clinical research and trial leadership ability in multiple projects.

• Must have a strong research and clinical background

Soft skills:

• project management skills in clinical research and the ability to manage multiple projects.

• Excellent communicationand problem-solving skills and ability to consistently keep track of all tasks

Technical skills:

• Deep knowledge of Watson LIMS or comparable application

• Proficient in Microsoft Office Applications including Excel, Word, and PowerPoint

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.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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.