Clinical Scientist, Ophthalmology

** Job title** :
Clinical Scientist, Ophthalmology

*
* Location:

** Cambridge, MA

** About the Job:*
* Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress in ophthalmology.

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

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.

** 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 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…