Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director, Clinical Leader, Translational & Experimental Medicine, CVM 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) Translational & Experimental Medicine Group, with a focus on drug development for metabolic and cardiovascular projects. The Sr. Director will have broad responsibilities including:
- 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.
- Accountable for the design the Translational Early Development Plan and the clinical development strategy for early stage compound(s), in collaboration with CVM Discovery, Biomarkers, Development, and other functional partners.
- Accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the Metabolism and Cardiovascular portfolio.
- Leading the Clinical Team, responsible for the timely completion, content, and quality of key deliverables including protocols, clinical study reports and submissions to health agencies
- Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations.
- Providing key input into diligence activities.
Qualifications for the Senior Director Clinical Leader include:
- MD (or equivalent) with a basic science research background or MD/PhD is required.
- Board certification in Internal Medicine (or Pediatrics) and Endocrinology is preferred, but backgrounds in Cardiology or Nephrology will be considered.
- Detailed and thorough understanding of metabolic disorders, including diabetes, obesity, and related disease (e.g., cardiovascular disease), in drug development diabetes, and in methodology relevant to clinical research in diabetes and metabolic disorders is required.
- Should be a recognized authority in metabolic disorders and complications, with a focus on drug development, as demonstrated by successful post-doctoral research and publications in metabolic disorders.
- Requires at least 7 years of experience in early development clinical research and development (including Phase 0-2a studies).
- Up to 10% annual travel (domestic and international) may be required.
United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research MDRequisition ID