Johnson & Johnson Careers

Senior Director Pediatric Product Development

Raritan, New Jersey
Clinical Research MD


Job Description

Requisition ID: 5170180627

Johnson and Johnson is recruiting for a Senior Director Pediatric Product Development to be located in Raritan, NJ.
 
At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
 
We are Johnson and Johnson  Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.

This physician will support the Vice President of the Child Health Innovation Leadership Department (CHILD) in advising all clinical teams and Compound Development Teams across all Therapeutic Areas in the implementation of Pediatric Programs to take advantage of Pediatric Exclusivity and comply with regulatory demands regarding pediatric studies.


He or she shall keep abreast of current scientific, regulatory, and operational knowledge of clinical trials in children. He or she shall keep a current knowledge of the preclinical aspects pertaining to pediatric drug development such as juvenile animal pharmacology and toxicology as well as the appropriate development of formulations suitable for children of different ages. This knowledge is to be disseminated to all therapeutic areas of the company and all the functions serving the therapeutic areas. He or she should also implement the highest ethical standards in the conduction of clinical research in children.

Responsibilities include:
  • Provide support to all CDTs conducting pediatric studies (participating and reviewing Proposed Pediatric Study Requests (PPSRs). Pediatric Study Plans (PSPs), and Pediatric Investigational Plans (PIPs) and their respective amendments before they are submitted to regulatory authorities.)
  • Review or draft pediatric protocols, policies and generate appropriate tools for clinical research in children.
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Qualifications
Qualifications for the Senior Director Pediatric Product Development include:
  • Requires an MD/DO degree, preferably a Pediatrician, with a minimum of 10 years' experience in drug development or a relevant experience to drug development
  • Relevant experience in regulatory requirements is highly desirable, since pediatric drug development is highly driven by regulatory requirements in the United States and Europe
  • Ability to work in a highly matrix organization that requires leading by influence
  • Up to 20% annual travel may be required (domestic and international)

Primary Location
United States-New Jersey-Raritan
Organization
Johnson & Johnson (6067)
Job Function
Clinical Research MD
Requisition ID
5170180627