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Sanofi Group Senior Clinical Scientist - Immunology and Inflammation in Cambridge, Massachusetts

OVERVIEW

This role is key to help the medical supervision of clinical studies by Clinical Research Directors and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) and Development Units of Sanofi R&D.

The primary purpose of the Senior Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) 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 or draft 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 include all clinical trials for projects in development (excluding Phase I in healthy subjects, POC managed by CEP) and clinical studies for marketed drugs or devices (e.g. registries), from scientific assessment of a clinical project to final deliverable. The applicant must be used to digital reporting tool, convinced and willing to promote their use. This position is specifically aimed to support early oncology development therefore experience in Oncology is a plus.

Under the guidance of his/her management, the senior Clinical scientist 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 Head Clinical Scientists and Medical Coding, and functionally 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 Senior 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.

MAIN RESPONSIBILITIES

  • Ensure scientific support for operational realization within the CSO 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…).

  • 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 is 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

REQUIRED KNOWLEDGE / SKILLS

  • Strong leadership is required, as the person may have to act as a CRD, or endorse CRD decision’s on his/her behalf

  • Scientific expertise or interest and ability to learn in the domain of assigned study/project.

  • High level of autonomy and motivation

  • Quality focused and well organized

  • Familiar with digital tools such as data analytics or agility to use them

  • Strong communication skills (verbal and written)

  • Multiple tasks handling and prioritization

  • Ability to analyze and interpret data-driven decision dashboards

  • Ability to synthesize the information, good presentation skills

  • Excellent decision-making and problem-solving capabilities

  • Capability to challenge decision and status quo

  • 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

  • Teaching skills, ability to mentor and train others

  • Experience of working internationally with Strong English skills (verbal and written if English is the second language

REQUIRED EDUCATION / EXPERIENCE

  • Bachelor’s degree with 10 years of experience in Clinical Research and/or Drug Development within pharma industry or CRO.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

#GD-SA

#LI-SA

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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