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. Join our Immunology and Inflammation Team as Senior Clinical scientist and you'll contribute to bring innovative drugs to patients and make a real impact for them all around the world while enjoying lots of opportunities to broaden your experience and hone your skills.

The primary purpose of the Clinical Scientist position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for clinical studies, on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.

Scope includes all clinical trials for projects in development (excluding studies managed by TMCP) and clinical studies for marketed drugs or devices (e.g. registries), from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD, ...).

Under the guidance of his/her manager in the I&I Therapeutic Area, 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 scientific documents, as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

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 operational realization for study(ies) or registries 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 (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form, etc.). Participates to 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
  
• 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 GPE or safety events of special interest)
  
• Help for the preparation, organization, conduct and minutes of Study Committees, follow the contracts with business support
  
• Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct
  
• Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings
  
• Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis and are able to develop good quality management practices, including guidelines, as regard to medical data review activities, using a data-driven and risk management approach
  
• Support to regulatory documents filing and archiving.
  
• Is assessing, providing cost elements related to the study support in collaboration with study team, including GPPM
  
• promote, track, and more widely accompany the usage of electronic reporting solutions (Smartrials or any IT digital tool) in the context of medical review/validation
  

About You

Skills that you have:

• Scientific expertise or interest and ability to learn in the domain of assigned study/project.
  
• Well organized, high level of autonomy and motivation,
  
• Leadership capabilities to give direction and organize activities on behalf of the CRD
  
• Quality focused, able to develop good practices, using a critical data-driven and risk management approach
  
• Familiar with digital tools such as data analytics or agility to use them
  
• Good communication skills (verbal and written)
  
• Multiple tasks handling and prioritization
  
• Ability to synthesize information, good presentation skills
  
• Ability to work autonomously and to efficiently provide status reports
  
• Ability to anticipate and timely escalate issues and to execute action plans
  
• Team and results oriented
  
• Experience in working internationally with strong English skills (verbal and written if English is not the native language)
  
• Knowledge of ICH, GCP
  

Required Education/Experience:

• PharmD, PhD or similar. Bachelor's and Masters' degrees considered for candidates with experience.
  
• Previous experience in Clinical Research and/or Clinical Drug Development (e.g., at least 3 years within pharma industry, academic research or CRO).
  

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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