Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Leader, Established Products (Women's Health, Urology and Pain) to be located in Titusville, NJ .
At the Janssen Pharmaceutical Companies of 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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com
for more information.
We are Janssen. 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
The Clinical Leader, Established Products (CL-EP), is involved in the lifecycle management of a variety of marketed products across a diverse group of therapeutic areas. This position is for the Women's Health, Urology and Pain areas. The CL-EP position supports the Therapeutic Area Portfolio Management Team and is dedicated to maximizing the value of this portfolio through the execution of all phases of clinical development. The CL-EP provides active medical and scientific contribution to cross-functional clinical teams to enable worldwide registrations for new indications and enhancements to the label.
Responsibilities for the Clinical Leader include:
- Leads Clinical Teams in the fulfillment of Phase IV commitments and other projects as required by regulatory authorities
- Executes clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications
- Participates in cross-functional teams for evaluation of new product ideas; reviews medical literature and related new technologies
- Additional medical affairs responsibility in the United States including but not limited to interaction with internal and external experts/thought leaders and oversight of Investigator Initiated Studies
- The CL-EP works with the Global Labeling Teams, Regulatory Affairs and Safety to update the Core Date Sheets, EU, US and other local labels for products within the therapeutic areas
- Collaborates with International teams on responses to requests from Health Authorities, worldwide; Phase-3 registration studies conducted by operating companies; and timely implementations of corrective actions as needed
Qualifications for the Clinical Leader include:
- Requires an MD/DO degree
- Board Certification in Women's Health, Neurology, Urology or Pain is desirable.
- Additional training in Women's Health, Urology, Pain or Epidemiology, PhD in a relevant discipline, or business/management training (MBA) is desirable
- Minimum of 2 years of academically based research experience is preferred
- Minimum of 5 years of drug development experience is preferred
- Minimum of 5 years highly successful industry/CRO experience is strongly preferred
- Managerial/supervisory experience is strongly preferred
- Up to 15-25% annual travel is required (domestic and international)
United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research MDRequisition ID