Sanofi · 1 day ago
Senior Clinical Research Director, Ophthalmology
Morristown, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Senior Clinical Research Director will lead clinical teams to deliver successful trials for novel therapeutics in Ophthalmologic Diseases, providing medical expertise and developing clinical strategies.
Health CareLife SciencePharmaceuticalTherapeutics
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 (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
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 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
Qualification
Required
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)
Preferred
Board certified or eligible in Ophthalmology
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
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