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
1. 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)
2. 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)
3. Participate in Study Team and monitoring team training on medical information
4. Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts
5. Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments
6. Help rationalize and document data collection needs quantitatively and qualitatively
7. Contribute to definition of centralized monitoring strategy in consistency with planned statistical analysis
Medical Monitoring & Data Review
8. Support study data validation and review processes
9. Assist CRD for Clinical Case review (safety events reported to GPE or safety events of special interest)
10. Review and assess adverse events and protocol deviations
11. Assist in preparation of safety reports and regulatory submissions
12. Communicate effectively with CRD and study team on potential safety signals or study risks
Study Committees & Documentation
13. Help with preparation, organization, conduct and minutes of Study Committees
14. Follow contracts with business support
15. Provide or prepare medical/scientific information/documentation/analysis for protocol preparation or study conduct
16. Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings
17. Support regulatory documents filing and archiving
Collaboration & Teamwork
18. Work closely with the Clinical Research Director (CRD) to implement study strategies and protocols
19. 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
20. Support CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with Clinical Trial Team (Monitoring Teams) or Pharmacovigilance
21. Collaborate with study team members to ensure alignment on study objectives and timelines
22. Participate in regular study team meetings to provide clinical input and updates
23. Partner with study team members to ensure data quality and integrity
Quality Management & Process Improvement
24. Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
25. Develop good quality management practices, including guidelines, regarding medical data review activities using data-driven and risk management approach
26. Ensure compliance with GCP, regulatory requirements, and company SOPs
27. Assess and provide cost elements related to study support in collaboration with study team, including GPPM
28. Promote, track, and accompany usage of electronic reporting solutions in context of medical review/validation
About You
Required Education & Experience:
29. Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field
30. 1-2 years of clinical development experience in pharmaceutical/biotech industry preferred
31. Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
32. Understanding of clinical trial processes and adverse event reporting
Preferred Qualifications:
33. Experience in Immunology/Inflammation therapeutic area
34. Clinical trial experience across multiple phases (Phase I-III)
35. Experience with clinical data management systems and eCRF platforms
36. Familiarity with medical terminology and disease pathophysiology
Skills & Competencies:
37. Scientific expertise or interest and ability to learn in the domain of assigned study/project
38. High level of autonomy and motivation
39. Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
40. Able to develop good quality management practices using data-driven and risk management approach
41. Quality focused and well organized
42. Strong attention to detail and accuracy in clinical documentation and data review
43. Ability to handle multiple tasks and to prioritize
44. Ability to synthesize information, good presentation skills
45. Excellent decision-making and problem-solving capabilities
46. Capability to challenge decisions and status quo
47. Ability to work autonomously and efficiently provide status reports
48. Ability to anticipate and timely escalate issues and define appropriate action plans
49. Team and results oriented
50. Teaching skills, ability to assist and train others
51. Strong scientific writing and communication skills
52. Strong English skills (verbal and written)
53. Ability to work effectively in cross-functional, matrix environment
Why Choose Us?
54. Bring the miracles of science to life alongside a supportive, future-focused team.
55. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
56. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
57. 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, discover
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 and check out our Diversity Equity and Inclusion actions at !
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.
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 .