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Clinical Scientist – Job description

Job title: Clinical scientist

• Grading Global: L3

• Hiring Manager: Pablo RENDO

• Location: Gentilly

About the job

Within Rare Disease Therapeutic Area (Development), this role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) and Development Units in Sanofi R&D. The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director, in the medical/scientific contribution for the clinical studies e.g: supporting operational activities pertaining to the abbreviated protocol/protocol/amended protocol development (such as Informed consent, committees charters development), support to validation and clinical case review of study data, review of study plans and study reports/publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, help manage study committees.

Scope includes all R&D clinical trials in gene therapy, from scientific assessment of a clinical project to final deliverable. The applicant must be able to use reporting tool, convinced and willing to promote their use. The applicant is a fast learner as the role can be assigned to any Therapeutic Area depending on needs.

Under the guidance of the CRD he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical review, as needed. He/she supports the CRD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

To better serve the activity, and depending on his/her experience, a Clinical Scientist can be dedicated to a specific task (e.g. answering questions of local teams, managing validation strategy etc.), following business needs.

Main Responsibilities:

• Ensure scientific support for realization of gene therapy study(ies) he/she is allocated to
• Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, etc.). Participates with the Study Team and monitoring team training on medical information
• Support CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
• Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of rationalizing and documenting the data collection needs quantitatively and qualitatively
• Help for the preparation, organization, conduct and minutes of Study Committees (eg. Steering committee, Adjudication Committee), follow the contracts with business support
• Support to regulatory documents filing and archiving

About you

Experience:

• Ph.D. preferred
• Previous experience in Clinical Research and/or Drug Development appreciated
• Scientific expertise or interest and ability to learn in the domain of assigned rare disease
• Therapeutic Area in gene therapy study/project

Soft and technical skills:

• Ability to support scientific and medical activities
• Able to develop good quality management practices
• Digital and data oriented
• Ability to handle multiple tasks and to prioritize
• Ability to anticipate and timely escalate issues and to define appropriate action plans

Language(s):

English skills (verbal and written ) if English is the second language

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com