J&J Family of Companies Sr. Director, Clinical Leader Ophthalmology, Phase 3 Gene Therapy in Raritan, New Jersey
Janssen is recruiting for a Sr. Director, Clinical Leader Ophthalmology, Phase 3 Gene Therapy for the Inherited Retinal Disease Program to be based ins Raritan, NJ or Springhouse, PA
Serve as a Clinical Leader in the Cardiovascular/Metabolism/Retina (CVMR), with a focus on drug development for retinal projects. The initial effort will be towards a first-in-class pivotal stage program with Accelerate to Value (ATV) status at Janssen indicating its importance to the organization.
Provide strategic, clinical, and scientific leadership of through all phases of clinical development
The Sr. Director will have broad responsibilities including:
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 the design and implementation of the Clinical Development Plan
Working with functional partners responsible for the clinical development strategy for the assigned development program(s)
Providing strategic 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, including FDA advisory committee meetings and/or CHMP presentations
Provides key input into diligence activities
Participates or leads cross-departmental or cross-functional projects with broad Janssen 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.
MD (or equivalent) is required.
Board certification in Ophthalmology is preferred
Excellent oral and written communication and presentation skills are required.
The ability to work with cross-functional teams in a matrix environment is required.
Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is preferred.
Requires at least 7 years of experience in clinical research and development (including Phase 2-3b studies).
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required.
Up to 15% annual travel (domestic and international) may be required.
United States-New Jersey-Raritan-920 US Highway 202
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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