Director, Clinical Development, Metabolism-5573140306
Description
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Clinical Development, Metabolism, located in Raritan, NJ.
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, oncology, infectious disease, diabetes, cardiovascular disease, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director will serve as a clinical leader in the Metabolism Development Group, with a focus on diabetes drug development. The position will have the following responsibilities: Working with functional partners, responsible for the clinical development strategy for the assigned development program; Providing strategic leadership on managing/addressing specific project related issues; Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads a clinical team in responding to medical and compound-related issues; Working with Regulatory Affairs and GCO to address any study or program-related issues, including responses to questions from Agencies and IRBs/ECs; Leading a clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports, submissions to health agencies, as well as providing key input to statistical analysis plans and the interpretation of statistical analyses.
Additional responsibilities include providing input and support for other metabolic development clinical programs and maintaining expertise in metabolic diseases and in relevant clinical research methodologies.
Qualifications
MD (or equivalent) with board certification in internal medicine (or pediatrics) and endocrinology (or related clinical experience sufficient to have detailed expertise in endocrinology and diabetes, such as nephrology or cardiology) is required. Recognized authority in metabolic disorders, as demonstrated by successful research and publications in metabolic disorders. This position requires at least 3 years of experience in clinical research and development (ideally in the conduct of Phase 2 -3b studies). Detailed and thorough understanding of metabolic disorders, including diabetes and obesity and in methodology relevant to clinical research in diabetes and metabolic disorders is a strong asset. Drug development experience is a plus. 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. Excellent oral and written communication and presentation skills are required. The ability to work with cross-functional teams in a matrix environment is preferred. This position may require from 10-15% annual travel (domestic and international).
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J2W: LI NA
Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Research MD
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