Job title: Clinical Scientist, Ophthalmology
Location: Cambridge, MA

This role is key to supporting the medical supervision of clinical studies by Clinical Research Directors (CRD) and/or clinical leads to ensure scientific management of clinical studies within Sanofi's ophthalmology therapeutic area. You will contribute to advancing innovative treatments for retinal diseases other vision-threatening conditions.

The primary purpose of the Clinical Scientist's position is to assist/support the Clinical Research Director in the medical/scientific contribution for ophthalmology clinical studies, including: supporting operational activities pertaining to protocol development (such as Informed Consent and committee charters), validation and clinical case review of study data, review of study plans and draft study reports/publications for accuracy, literature review and analysis, and preparation of responses for investigators, study teams, ethics committees, or regulatory authorities.

The scope includes all R&D clinical trials in ophthalmology, from scientific assessment of a clinical project to final deliverable. The applicant must be able to use digital reporting tools and be convinced and willing to promote their use. The applicant is a fast learner who can adapt to evolving therapeutic area needs.

Under the guidance of the CRD, you will collaborate with Coding specialists, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representatives, and Medical Writers on high-quality medical review. You will support the CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

Main Responsibilities:

Clinical Study Support

• Ensure scientific support for the realization of ophthalmology study(ies) by securing the operationalization of the medical validation/review plan (reports and trackers)
• Support design and execution of multiple clinical studies defined within the ophthalmology development plan
• 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
• Participate in CRF design, review CRF design and completion instructions
• 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.
• Provide clinical landscape and benchmark updates.
• 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.

Required Knowledge & Skills

Technical Expertise:

• 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.

Preferred Qualifications:

• Experience with gene therapy or novel therapeutic modalities in ophthalmology
• Familiarity with retinal diseases, AMD, geographic atrophy, or other ophthalmology indications
• Experience with audit responses and regulatory inspections

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.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

The salary range for this position is:
$148,500.00 - $214,500.00

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.