Senior Clinical Research Director, Neurology, Ophthalmology and Gene Therapy Development
Cambridge, Massachusetts, Chilly-Mazarin, France
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The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases. The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. The Sr CRD will work closely with researchers in the Sanofi Genomic Medicine Unit to bring two early ophthalmology projects into development.
The Neurology, Ophthalmology and Gene Therapy Development unit is a project-based organization. CRDs typically report to the Global Project Head and lead the cross-functional Global Clinical Team to establish the development strategy and execute the development plan. We are looking for individuals with curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.
Some of the Clinical Research Director’s (CRD) core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and Technical Expertise:
Has and maintains deep scientific, technical, and clinical expertise in ophthalmology
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.
Serves as the Study Director and Medical Monitor 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, Target Product Profile 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 CRDs and clinical scientists in the same program, as needed
The CRD is representative for Clinical Development:
at the Global Project Team
in meetings with Regulatory Agencies
in Steering Committees (SC) and Data Monitoring Committees (DMC)
at the Benefit Risk Assessment Committee
at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)
Medical Doctor (MD) highly preferred, ophthalmology specialist
More than 5 years of clinical or scientific experience, or more than 10 years industry experience within the field of ophthalmology and retinal diseases
Fluent in English (verbal and written)
Board certified or eligible in Ophthalmology
Completion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery, neuro-ophthalmology
Strong scientific and academic background with deep understanding of retina and eye disease
Clinical research or pharmaceutical experience in ophthalmology
Knowledge of drug development
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
Will consider remote (EST) for the right candidate
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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.
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