Job Description - Senior Director, Clinical Leader Ophthalmology and Neuroscience (2506233613W)Senior Director, Clinical Leader Ophthalmology and Neuroscience - 2506233613WPOSITION SUMMARY:The incumbent will serve as a Clinical Leader in Ophthalmology, Neuroscience, with a focus on drug development for retinal projects. The initial effort will be towards a first-in-class gene therapy program for age-related macular degeneration, a prevalent and blinding condition. They will provide strategic, clinical, and scientific support through all phases of clinical development.ESSENTIAL FUNCTIONS:Provides active medical and scientific contribution to a matrixed cross-functional Compound Development Team and the Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business-related disciplines.Accountable for implementation of the Clinical Development Plan.Working with functional partners responsible for the clinical development strategy for the assigned development program(s).Providing leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the SO and Johnson and Johnson Innovative Medicine, Research & Development leadership teams on development plans or program-related issues.Working with global clinical operations, Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues.Working with Regulatory Affairs and global clinical operations with regard to responses to questions from Health Authorities and IRBs/ECs.Leading the clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports and submissions to health agencies.Supervising and contributing to the timely completion and quality of clinical study reports, including providing key input to statistical analysis plans and the interpretation of statistical analyses.Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations.Participates or leads cross-departmental or cross-functional projects with broad Johnson and Johnson Innovative Medicine impact.Builds credible relationships with opinion leaders and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.QualificationsEducation and Experience:MD (or equivalent) is required.Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is required.Requires at least 7 years of experience in clinical research and development (including Phase 2-3b studies).Exceptional interpersonal and communication skills, with
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