Clinical Scientist

Job title
:
Clinical Scientist

• Location:
  
  Cambridge MA

The Lunsekimig project team is part of Early Development in the Inflammation & Immunology Therapeutic Area  team is developing a novel pentavalent, bispecific Nanobody for the treatment of asthma and other “Type 2” inflammatory diseases. Lunsekimig is being evaluated across multiple respiratory indications as well as atopic dermatitis.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

We’re an R&D–driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies, on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set‑up to clinical study report in compliance with quality and regulatory processes.

• Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (ie abbreviated protocol/protocol/amended protocol, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary).
• Supports Clinical Research Director in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project.
• Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan.
• Support the Clinical Lead and CRD to prepare presentations to obtain endorsement of the clinical strategic plan with the appropriate governance committees.
• Support program strategy including clinical development plan and regulatory needs.
• Work in partnership with CRD or Clinical lead as functional liaison (data management, biostatistics, medical writing, pharmacovigilance, regulatory, clinical operations, translational medicine) as well as interact with and support Project team members, project management, medical affairs.

• Support the design and execution of clinical studies defined within development plan.
• Support the preparation of key clinical documents to be prepared for clinical trials (protocols, informed consent, charters, benefit risk assessments).
• Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity.
• Develops study specific training material and participates in the Investigators, Study Team, and monitoring team training on medical information.
• Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analyses and is involved in study data validation and review processes, supports the CRD for the Clinical Case review (safety events reported to GPV or adverse events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
• Understand data collection, data flow, and data validation processes, including medical validation and review procedures through to data analysis. Develop high-quality management practices and guidelines for medical data review activities using a data‑driven and risk‑based approach.
• Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings.
• Suppo…