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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.
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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
- Provides key input into diligence activities
- 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.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
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 the ability to build strong relationships and influence without reporting authority.
- Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations.
- Up to 15% annual travel (domestic and international) may be required.
Required Technical Knowledge and Skills:
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Special Training or Certification:
- Board certification in Ophthalmology is preferred
The anticipated base pay range for this position is $226,000 to $391,000 USD.
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, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, 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. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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.