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Discovery & Pre-Clinical/Clinical Development

Director, Late Development Clinical Lead - Retina

  • Título Director, Late Development Clinical Lead - Retina
  • Função Discovery & Pre-Clinical/Clinical Development
  • Sub função Clinical Development & Research & MD
  • Categoria Director, Clinical Development & Research - MD (PL9)
  • Local Raritan, New Jersey, United States
  • Postado
  • ID obrigatória 2406173830W
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Descrição

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 https://www.jnj.com/.  

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:

·         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.

Qualificações

Qualifications for the Director Clinical Leader include:

  • 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 required.
  • Requires at least 3 years of experience in clinical research and development (including Phase 2-3b studies) and/or clinical practice preferred.
  • 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.

The anticipated base pay range for this position is $186,000 to $322,000.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.  Additional information can be found through the link below. 

 

For additional general information on Company benefits, please go to: -  https://www.careers.jnj.com/employee-benefits

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

 

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