Director, Late Development Clinical Lead - Retina
Company: Disability Solutions
Location: Raritan
Posted on: April 20, 2024
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Job 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 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.
Keywords: Disability Solutions, New Brunswick , Director, Late Development Clinical Lead - Retina, Healthcare , Raritan, New Jersey
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