Senior Clinical Scientist

Job Summary

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

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 projects

• 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

• Supervise assigned clinical scientist on common projects

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

• Background: PhD in any biomedical discipline, post-doctoral studies in hematology / oncology is preferred

• Must have at least 5 years of clinical development experience in pharmaceutical industry or CRO; preferably in hematology/ oncology clinical trial implementation

• 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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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