Senior Clinical Research Director, Ophthalmology

Job Title: Senior Clinical Research Director

Location: Morristown, NJ Cambridge, MA

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.

• Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs
• Establish clinical development strategy and lead clinical team, collaborate with other medical and clinical scientific experts, clinical development scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions
• Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)
• Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities.
• Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, has the capacity to train them on the medical/scientific strategy by indication

• Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

• Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available
• Leads the clinical development including planned life cycle management (LCM)
• Ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team
• Implements strategies to identify, monitor and resolve clinical program/trial issues.
• Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data.
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders
• Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).
• Provides clinical input to Statistical Analysis Plans (SAP), Target Product Profile (TPP) and Risk Management Plan
• Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators
• Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project
• Lead the medical/clinical assessment of…