Clinical Scientist Full-time

Clinical Scientist

Location: Cambridge, MA / Morristown, NJ

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

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.