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.