Reporting to the GPH , the Senior Clinical Scientist is noted as the clinical expert for the execution of dedicated studies of the assigned program. The role requires a well-organized, operationally focused, individual with good analytical skills and the ability deliver multiple operational tasks.

The role of the Clinical Scientist is to:

• Provide medical expertise to the clinical studies and/or registries (eg: protocol, Key Results, Clinical Study Report)
• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)

• Contribute to the Abbreviated Protocol, the final protocol and protocol amendments and the clinical study report for their project

• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Key responsibilities include

• Develop the abbreviated protocol
• Develop the final protocol and protocol amendments
• Medical support to clinical operation team during the clinical feasibility
• Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
• Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
• Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
• Participate in the elaboration of training material and presentations at the investigator meetings
• Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO
• Answer to medical questions raised by EC/IRBs, sites
• Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function

• Provide operational expertise to project clinical sub team, as needed

Job requirements

• PhD in any biomedical discipline, post-doctoral studies in hematology / oncology is preferred
• Must have at least 5 years of experience in clinical development; early clinical development experience preferred
• Computer skills
• Fluency in written and spoken English
• Ability to work within a matrix model
• Open to work in an international and intercultural environment
• Open-minded to apply and learn digital solutions

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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