Johnson & Johnson Careers
Senior Director Pediatric Product Development
Requisition ID: 5170180627
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.
- 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.
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)
United States-New Jersey-Raritan
Johnson & Johnson (6067)
Clinical Research MD