- 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 input to and 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 CVMR and Janssen leadership teams on development plans or program-related issues
- Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues
- Working with Regulatory Affairs and GCO 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
- Provides key input into diligence activities
- Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.
- Builds credible relationships with external partners (e.g. principal investigators, sub-investigators and opinion leaders) and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.
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Director, Late Development Clinical Lead - Raritan, United States - Johnson & Johnson
Description
Johnson & Johnson is recruiting for a Director, Clinical Leader - Retina to be located in Raritan, NJ .At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at
The incumbent will serve as a Clinical Leader in the Retina therapeutic area, 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, and provide strategic, clinical, and scientific support through all phases of clinical development.
The Director will have broad responsibilities including:
