CLINICAL LEADER-00000Q40
Description
Janssen Research and Development, LLC (JRD) one of the J&J Family of Companies, is recruiting for a Director, Clinical Leader, located in either Titusville or Raritan, NJ, Spring House, PA or Beerse, Belgium. Other locations that would not impair interactions with the study teams and other GPH colleagues can be considered.
JRD Pharmaceutical 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.
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 (CL) position is in the Global Public Health (GPH) organization. GPH is involved in addressing the medical needs of patients in the developing world and resource limited settings with J&J capabilities, pharmaceuticals and other products.
GPH also explores and executes newer, more effective collaborations with governments, NGOs (e.g. WHO, MSF), foundations (e.g., B&M Gates Foundation) and academic leaders (e.g. Partners in Health, Liverpool School of Public Health)
The CL position will be filled by a high performing individual who demonstrates outstanding leadership, organizational, interpersonal and communication skills. The CL must be an MD, should have expertise in one (or more) disciplines including a medical specialty (infectious diseases preferred), biostatistics and epidemiology, global public health or related fields. Extensive experience managing clinical trials and the overall process of clinical development is essential, and an understanding of, and interactions with, the global regulatory agencies is preferred. The CL will support the development of drugs to treat two parasitic diseases that affect millions of patients in countries around the world. The ability to work across different areas within Infectious Diseases is also an essential skill. In addition, the CL will also support a unique development program for a drug for a rare genetic disease called Niemann-Pick Type C.
This individual will serve as the CL on the Compound Development Teams and report to the Compound Development Team Leader. The CL will be responsible for all clinical development efforts including study design, protocol development and execution of clinical studies, including safety monitoring, in all phases of clinical development. The CL will also provide scientific input to other projects within GPH based on her/his expertise and training. The CL will collaborate with Regulatory Affairs in determining strategies for Health Authority interactions IND/CTA, NDA and other regulatory submissions, interactions, requests or investigations. The CL will have a major role in maintaining product compliance globally by working with different operating companies (that maintain the Marketing Authorizations) to maintain product compliance in these markets. This can evolve managing safety or product quality issues that may arise, and assuring that the labeling is up to date.
The CL will be involved in the interpretation and writing of Clinical Study or other reports, and assist in the preparation of oral and written results of product research in preparation for FDA (or other Health Authority) submissions and advisory committees. The CL participates in the preparation of abstracts and manuscripts of clinical research findings for publication and presentations to relevant meetings, or FDA meetings, including advisory committees. The CL will work with the commercial organizations to explore and identify new marketing opportunities. The CL is expected to remain a subject matter expert in her/his field by reading the literature, attending appropriate meetings, and participating in appropriate CME courses as needed.
Qualifications
MD or DO is required. Additional board certification in infectious disease, biostatistics and epidemiology, or public health is highly desired. Board certifications in other medical subspecialty, MD/PhD in a relevant discipline is also highly desirable.
A minimum 5 years of academic experience in clinical research/drug development is preferred. A minimum of 5 years of progressive responsibilities in the pharmaceutical industry in an R&D position is required. Previous experience with patients or research in the developing world is highly desirable. Interfacing with early development activities, medical affairs, regulatory affairs and marketing teams strongly preferred. Experience IND and NDA submissions launch and successful commercialization of a new product is highly desired.
Experience in a leadership role within a multi-functional R&D organization is desired along with strong interpersonal skills, mentoring and coaching skills. 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. Must have the ability/willingness to travel. Travel (including some international) is expected to consume up to 20% of time.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA.
Primary Location:North America-United States-New Jersey-Titusville
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Research & Development, LLC. (6084)
Job Function: R&D
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