Principal Scientist
Company: Disability Solutions
Location: Danvers
Posted on: May 3, 2024
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Job Description:
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for
a Principal Clinical Research Scientist located in Danvers, MA. 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 We are looking
for a strong leader to support the development and design of
Abiomed's global clinical studies with the focus on sound clinical
evidence generation to drive better patient outcomes with the use
of Abiomed products. The Principal Clinical Research Scientist will
oversee clinical studies within the Clinical and Regulatory Affairs
department. The ideal candidate will be able to directly influence
a strong evidence generation engine for Abiomed products. Primary
Duties and Responsibilities: --- Execute on Abiomed's scientific
objectives within Abiomed-sponsored clinical studies --- Serve as
scientific lead on Abiomed-sponsored clinical studies, and be the
point person for scientific questions during execution of these
studies --- Own protocol development, revisions, submission, and
approval, including consensus building with study steering
committee and principal investigators and communication with FDA
--- Work closely with biostatistics team to evaluate study design
options and analyze study data to support study decisions related
to protocol development and study execution --- Support the
production of trial-related interim analyses, hypothesis testing,
publications, and presentations --- Own steering committee meetings
and serve as scientific lead on investigator/research coordinator
meetings --- Provide scientific support for development of
electronic data capture (EDC) for Abiomed-sponsored clinical
studies --- Responsible for scientific content for all
trial-related documents --- Own annual and final report content
development, and coordination of content from various stakeholders
--- Develop, maintain, and review periodic study reports - review
for outliers, ranges, and potentially problematic data; identify
and communicate root causes and suggest possible solutions,
document data observations, and follow pre-established processes
and procedures --- Develop and execute publication/presentation
charters for clinical studies --- Ensure data analysis integrity
for clinical studies within scope of role --- Drive strong
publication/presentation cadence for Abiomed sponsored clinical
studies --- Execute on the regulatory pathway required for new
investigational devices and for indication expansion globally ---
Conduct literature review and clinical data review to support
regulatory submissions and CERs --- Cross-collaboration with other
Medical Office departments
Keywords: Disability Solutions, Newton , Principal Scientist, Other , Danvers, Massachusetts
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