Clinical Scientist
Sanofi

Job Info

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Job Title: Clinical Scientist

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

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 draft 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 for Tolebrutinib, from scientific assessment of a clinical project to final deliverable. The applicant must be able to use digital 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 with minimal supervision (e.g. answering questions of local teams, managing validation strategy etc...), following business needs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Ensure scientific support for realization of tolebrutinib study(ies) he/she is allocated to by securing the operationalization of the medical validation/review plan (reports and trackers)
  
• Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form). Participates with the Study Team and monitoring team training on medical information
  
• Is assessing, providing cost elements related to the study support in collaboration with study team, including planning management
  
• 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
  
• Contribute to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved some of the study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to Pharmacovigilance or safety events of special interest)
  
• Help for the preparation, organization, conduct and minutes of Study Committees (eg. IDMC), follow the contracts with business support
  
• Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings
  
• Support to regulatory documents filing and archiving.
  

About You

Required Knowledge and Skills:

• Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
  
• Able to develop good quality management practices, including guidelines, as regard to medical data review activities, using a data-driven and risk management approach
  
• Digital and data oriented
  
• Scientific expertise or interest and ability to learn in the domain of assigned study/project
  
• Ability to take responsibilities on medical activities or endorse CRD decisions on his/her behalf
  
• Quality focused and well organized
  
• Ability to handle multiple tasks and to prioritize
  
• Strong communication skills (verbal and written)
  
• Ability to synthesize the information, good presentation skills
  
• Ability to work autonomously and to efficiently provide status reports
  
• Ability to anticipate and timely escalate issues and to define appropriate action plans
  
• Team and results oriented
  
• Strong English skills (verbal and written if English is the second language)
  

Required Education/Experience:

• Ph.D. preferred.
  
• Previous experience in Clinical Research and/or Drug Development
  
• 3+ years of industry experience (including both research and clinical development)
  
• 1+ years experience as clinical scientist
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks' gender-neutral parental leave.
  

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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