Principal Scientist, Clinical Research

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

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research – Non-MD

Job Category:
Scientific/Technology

All Job Posting Locations:
West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland

Job Description:

We are searching for the best talent for a Principal Scientist, Clinical Research located in West Chester, PA.

Purpose: Operating on behalf of the Medical Device Group, this individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:


* Reports to the Franchise Platform Leader or Sn Clin Res Mgr., MD CR&D;


* Is responsible for Clinical R&D activities for assigned projects, including:


* Develops and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g.

Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.), ensuring cross- functional alignment;


* Is responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);


* Ensures input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS.


* Leads in study design to develop appropriate clinical trials to meet the NPD / LCM needs.


* Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc.


* Contributes in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspe...