Clinical Scientist

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Job Title: Clinical Scientist

Location: Cambridge, MA / Morristown, NJ

About The Job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Position Overview

This role is key to supporting the medical supervision of clinical studies by Clinical Research Directors (CRD) and ensuring scientific management of clinical studies performed by the Clinical & Sciences Operations Platform (CSO) and Development Units.

The primary purpose of the Clinical Scientist's position is to assist/support the CRD and the study team in the medical/scientific contribution for clinical studies, including supporting operational activities pertaining to protocol development, validation and clinical case review of study data, review of study plans and reports, medical/scientific information search, literature review and analysis, and assistance in preparing responses for investigators, study teams, ethics committees or regulatory authorities.

The scope includes all clinical trials for projects in development. This position is specifically aimed to support Inflammation and Immunology development

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

Clinical Study Support

• Ensure scientific support for operational realization for assigned study/studies or registries by securing the operationalization of the medical validation/review plan (reports and trackers)
• Contribute to preparation and/or review of documents requiring scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, trial disclosure forms)
• Participate in Study Team and monitoring team training on medical information
• Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
• Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments
• Help rationalize and document data collection needs quantitatively and qualitatively
• Contribute to definition of centralized monitoring strategy in consistency with planned statistical analysis
  
  

Medical Monitoring & Data Review

• Support study data validation and review processes
• Assist CRD for Clinical Case review (safety events reported to GPE or safety events of special interest)
• Review and assess adverse events and protocol deviations
• Assist in preparation of safety reports and regulatory submissions
• Communicate effectively with CRD and study team on potential safety signals or study risks
  
  

Study Committees & Documentation

• Help with preparation, organization, conduct and minutes of Study Committees
• Follow contracts with business support
• Provide or prepare medical/scientific information/documentation/analysis for protocol preparation or study conduct
• Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings
• Support regulatory documents filing and archiving
  
  

Collaboration & Teamwork

• Work closely with the Clinical Research Director (CRD) to implement study strategies and protocols
• Under guidance of CRD, collaborate with Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers (GSMs and RSMs), Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) as needed
• Support CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with Clinical Trial Team (Monitoring Teams) or Pharmacovigilance
• Collaborate with study team members to ensure alignment on study objectives and timelines
• Participate in regular study team meetings to provide clinical input and updates
• Partner with study team members to ensure data quality and integrity
  
  

Quality Management & Process Improvement

• Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
• Develop good quality management practices, including guidelines, regarding medical data review activities using data-driven and risk management approach
• Ensure compliance with GCP, regulatory requirements, and company SOPs
• Assess and provide cost elements related to study support in collaboration with study team, including GPPM
• Promote, track, and accompany usage of electronic reporting solutions in context of medical review/validation
  
  

About You

Required Education & Experience:

• Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field
• 1-2 years of clinical development experience in pharmaceutical/biotech industry preferred
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
• Understanding of clinical trial processes and adverse event reporting
  
  

Preferred Qualifications

• Experience in Immunology/Inflammation therapeutic area
• Clinical trial experience across multiple phases (Phase I-III)
• Experience with clinical data management systems and eCRF platforms
• Familiarity with medical terminology and disease pathophysiology
  
  

Skills & Competencies

• Scientific expertise or interest and ability to learn in the domain of assigned study/project
• High level of autonomy and motivation
• Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
• Able to develop good quality management practices using data-driven and risk management approach
• Quality focused and well organized
• Strong attention to detail and accuracy in clinical documentation and data review
• Ability to handle multiple tasks and to prioritize
• Ability to synthesize information, good presentation skills
• Excellent decision-making and problem-solving capabilities
• Capability to challenge decisions and status quo
• Ability to work autonomously and efficiently provide status reports
• Ability to anticipate and timely escalate issues and define appropriate action plans
• Team and results oriented
• Teaching skills, ability to assist and train others
• Strong scientific writing and communication skills
• Strong English skills (verbal and written)
• Ability to work effectively in cross-functional, matrix environment
  
  

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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The Salary Range For This Position Is

$122,250.00 - $176,583.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

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