- 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 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.
- 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
- 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
- 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.
Senior Clinical Research Director, Ophthalmology - Morristown - Sanofi US
Description
Job Title: Senior Clinical Research Director
Location: Morristown, NJ Cambridge, MA
About the Job
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.
Main Responsibilities
Scientific and Technical Expertise
Other Responsibilities
About You
Basic Qualifications
Preferred Qualifications
Why Choose Us?
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Afficative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at
US and Puerto Rico Residents Only
North America Applicants Only
The salary range for this position is: $236, $393,750.00
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.
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