Senior Clinical Research Director, Ophthalmology in Cambridge

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. The Senior Clinical Research Director (CRD) is an expert clinical lead for one or several indications in the Development of an R&D program and is responsible for leading clinical team(s) to deliver successful clinical trials for novel therapeutics for Ophthalmologic Diseases. The role requires clinical leadership, organisation skills, strategically and operationally focused, resourceful individual with capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver to multiple operational tasks. We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.

Main Responsibilities:

• 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.
• 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.
• 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 and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases.
• Understand and keep updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest.
• Critically read and evaluate relevant medical literature with deep understanding of the data and status from competitive products.
• Maintain visibility within the therapeutic area to maintain credibility with internal and external stakeholders.

Other Responsibilities:

• Designs the global clinical development strategy and generates the Clinical Development Plan; 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.
• 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.
• 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 license-in opportunities, as needed.
• Manage other study physicians (CRDs) and clinical scientists in the same program, as needed.
• Author or co-author manuscripts and abstracts.
• Establishes and maintains appropriate collaborations with key opinion leaders or advisory boards.
• Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering committees, benefit-risk assessment committee, and at the submission task force.

About You

• Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred.
• Minimum 5 years of clinical trial and/or clinical development experience.
• Fluent in English (verbal and written).
• Board certified or eligible in Ophthalmology preferred.
• Strong scientific and academic background with deep understanding of retina and eye diseases.
• Clinical trial or pharmaceutical experience in ophthalmology.
• Knowledge of drug development, ocular gene therapy, regulatory strategy.
• Good networking ability in cross-cultural environment.
• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization.
• Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
• Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills.

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 recognises 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.