Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Sr. Director Clinical Leader, Metabolism to be located in Raritan, 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 Sr. Director will serve as a clinical leader in the Cardiovascular/Metabolism (CVM) Development Group, with a focus on drug development for metabolic projects. The Sr. Director will have broad responsibilities including:
- Working with functional partners responsible for the clinical development strategy for assigned development program(s)
- Providing strategic leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVM and Janssen leadership teams on development plans or program-related issues
- Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues
- Working with Regulatory Affairs and GCO with regard to responses to questions from Health Authorities and IRBs/ECs
- Leading the clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports and submissions to health agencies
- Supervising and contributing to the timely completion and quality of clinical study reports, including providing key input to statistical analysis plans and the interpretation of statistical analyses
- Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
Qualifications for the Sr. Director Clinical Leader include:
- MD (or equivalent) is required.
- Board certification in Internal Medicine (or Pediatrics) and Endocrinology is preferred
- Related clinical experience sufficient to have detailed expertise in Endocrinology and Diabetes such as Nephrology or Cardiology will be considered. Clinical experience in Obesity a plus
- Must have excellent leadership skills and experience.
- Excellent oral and written communication and presentation skills are required. The ability to work with cross-functional teams in a matrix environment is required.
- Should be a recognized authority in metabolic disorders, with a focus on drug development, as demonstrated by successful post-doctoral research and publications in metabolic disorders.
- Detailed and thorough understanding of metabolic disorders, including diabetes and obesity, in drug development diabetes, and in methodology relevant to clinical research in diabetes and metabolic disorders is required.
- Requires at least 7 years of experience in clinical research and development (including Phase 2-3b studies).
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required.
- Up to 15% annual travel (domestic and international) may be required.
United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research MD