Clinical Scientist, Ophthalmology

Main Responsibilities

• Ensure scientific support for the realization of ophthalmology study(ies) by securing the operationalization of the medical validation/review plan (reports and trackers)
• Perform clinical review and analysis of data listings, patient profiles, and essential study data within statistical reports and partner with Data Management in generating relevant queries
• Support design and execution of multiple clinical studies defined within the ophthalmology development plan
• Support CRD and Study Team with study start-up, site opening, enrollment monitoring, and support.
• Documentation & Regulatory Contribute to preparation and/or review of documents related to studies requiring scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communications to internal or external partners, study plans, study reports, trial disclosure form)
• Support the preparation of key clinical documents for clinical trials (protocols, informed consent, benefit-risk assessments)
• Support CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts involved in the study/project
• Support regulatory documents filing and archiving.
• Data Management & Quality Contribute to definition of the centralized monitoring strategy in consistency with the planned statistical analysis
• Support study data validation and review processes, including Clinical Case review (safety events reported to Pharmacovigilance or safety events of special interest)
• Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments
• Help rationalize and document data collection needs quantitatively and qualitatively.
• Committee & Stakeholder Management Help with preparation, organization, conduct, and minutes of Study Committees (e.g., IDMC)
• Support CRD in organizing/leading Steering Committees, Data Monitoring Committees, and Adjudication Committee meetings
• Follow contracts with business support
• Participate with Study Team and monitoring team training on medical information.
• Strategic & Scientific Contribution Maintain deep scientific, technical, and clinical expertise in ophthalmology
• Critically read and evaluate relevant literature with deep understanding of data and status from competitive products
• Build and maintain a strong network of internal and external collaborations, opinion leaders, and investigators
• Support interactions with Sanofi internal governance bodies, external partners, key opinion leaders, investigators, and committees.
• Project Management Assess and provide cost elements related to study support in collaboration with the study team, including planning management
• Driven individual and performance-oriented with ability to work along agreed timelines.

About You

• Basic Qualifications: Master's degree required in Biomedical Science, Life Sciences, Pharmaceutical Sciences, or related scientific field; PhD, PharmD, or MD in Biomedical Science, Life Sciences, Pharmaceutical Sciences, or related scientific field preferred
• 3+ years of industry experience in clinical research and/or drug development
• Experience in ophthalmology clinical trials is required

Technical Expertise Required

• Knowledge & Skills: Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
• Able to develop good quality management practices, including guidelines, regarding medical data review activities, using a data-driven and risk management approach
• Digital and data-oriented mindset
• Proficient in clinical literature and critical interpretation of clinical study results
• Experience with supporting preparation and execution of clinical trials
• Experience with basic statistical principles and techniques of data analysis, interpretation, and clinical relevance
• Knowledge of translational medicine and biomarkers

Collaboration & Leadership

• Ability to take responsibility for medical activities and endorse CRD decisions independently
• Proven experience collaborating effectively with cross-functional, interdisciplinary global teams and communicating clearly with all organizational levels, including investigators, vendors, and CROs
• Strong leadership, interpersonal, and presentation skills with an open, transparent, and collaborative working style

Operational Excellence

• Quality-focused, well-organized, and results-oriented with ability to manage multiple tasks, prioritize effectively, and work autonomously
• Strong problem-solving, conflict-resolution, and decision-making skills with ability to anticipate and escalate issues proactively, defining appropriate action plans