description du poste

Job Description - Senior Director, Clinical Leader Ophthalmology and Neuroscience (2506233613W)

Senior Director, Clinical Leader Ophthalmology and Neuroscience - 2506233613W

POSITION 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.

Qualifications

Education 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