Clinical Leader, Established Products-00000TE0
Description
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Clinical Leader, Established Products, located in Titusville, NJ, High Wycombe, UK, or Singapore.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
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. The areas are divided into three portfolios: Women’s Health and Urology (also includes Antifungals, Antihelminths, and Oncology); Pain/CNS (Psychiatry and Neurology); and Internal Medicine (Anti-Infectives, Gastroenterology, and Cardiovascular). 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 US and worldwide registrations for new indications and enhancements to the label.
The CL-EP works with the Global Labeling Teams, Regulatory Affairs and GMS to update the Core Date Sheets, SPC's, USPI's and local labels for products within the therapeutic areas; Fulfills Phase IV commitments and other projects as required by regulatory authorities; Collaborates with international teams on: requests from worldwide Health Authorities, conduct of Phase 3 registration studies by operating companies, and assurance of timely implementations of corrective actions as needed; Executes clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications. The CL-EP leads teams for preparing development plans, protocols, CSRs and documents for regulatory filings. The CL-EP is responsible for medical monitoring and safety reporting of clinical studies, acts as a liaison between company and investigators, and develops relationships with opinion leaders and key regulatory officials; Participates in cross-functional teams for evaluation of new product ideas; reviews medical literature and related new technologies.
Qualifications
MD/DO degree is required
Board Certification in respective Therapeutic Area is preferred
Additional training in Therapeutic Area, PhD in a relevant discipline, or business/management training (MBA) is preferred
At least 2 years of academically based research experience is required
At least 5 years of drug development experience is required
At least 5 years highly successful industry/CRO experience is strongly preferred
Managerial/supervisory experience strongly preferred
Outstanding oral and written communication skills (including report development) are essential
Success working in a Matrix environment a strong plus
Candidate should possess strong problem solving skills for developing creative solutions and meeting project objectives
Candidate should have demonstrated ability of strategic thinking and contingency planning with respect to EP TA objectives
Up to 15-25% yearly travel required (International and Domestic)
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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Primary Location:North America-United States-New Jersey-Titusville
Other Locations:Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Asia Pacific-Singapore-Singapore-Singapore
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD
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