Clinical Scientist

Job Title: Clinical Scientist

Location: Cambridge, MA / Morristown, NJ

About the job

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.

Position Overview

This role is key to supporting the medical supervision of clinical studies by Clinical Research Directors (CRD) and ensuring scientific management of clinical studies performed by the Clinical & Sciences Operations Platform (CSO) and Development Units.

The primary purpose of the Clinical Scientist's position is to assist/support the CRD and the study team in the medical/scientific contribution for clinical studies, including supporting operational activities pertaining to protocol development, validation and clinical case review of study data, review of study plans and reports, medical/scientific information search, literature review and analysis, and assistance in preparing responses for investigators, study teams, ethics committees or regulatory authorities.

The scope includes all clinical trials for projects in development. This position is specifically aimed to support Inflammation and Immunology development

About Sanofi

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.

Main Responsibilities:

Clinical Study Support

• Ensure scientific support for operational realization for assigned study/studies or registries by securing the operationalization of the medical validation/review plan (reports and trackers)

• Contribute to preparation and/or review of documents requiring scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, trial disclosure forms)

• Participate in Study Team and monitoring team training on medical information

• Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts

• Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments

• Help rationalize and document data collection needs quantitatively and qualitatively

• Contribute to definition of centralized monitoring strategy in consistency with planned statistical analysis

Medical Monitoring & Data Review

• Support study data validation and review processes

• Assist CRD for Clinical Case review (safety events reported to GPE or safety events of special interest)

• Review and assess adverse events and protocol deviations

• Assist in preparation of safety reports and regulatory submissions

• Communicate effectively with CRD and study team on potential safety signals or study risks

Study Committees & Documentation

• Help with preparation, organization, conduct and minutes of Study Committees

• Follow contracts with business support

• Provide or prepare medical/scientific information/documentation/analysis for protocol preparation or study conduct

• Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings

• Support regulatory documents filing and archiving

Collaboration & Teamwork

• Work closely with the Clinical Research Director (CRD) to implement study strategies and protocols

• Under guidance of CRD, collaborate with Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers (GSMs and RSMs), Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) as needed

• Support CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with Clinical Trial Team (Monitoring Teams) or Pharmacovigilance

• Collaborate with study team members to ensure alignment on study objectives and timelines

• Participate in regular study team meetings to provide clinical input and updates

• Partner with study team members to ensure data quality and integrity

Quality Management & Process Improvement

• Understand data collection, data flow, data validation, including medical validation and