Johnson & Johnson Careers
Medical Leader HIV/NTM
Clinical Research MD
Requisition ID: 1805678555W
Global Public Health (GPH), a division of Janssen Pharmaceutical Research & Development (JRD), one of the Johnson & Johnson's Family of Companies, is recruiting a Director, Medical leader (ML), to be located in Beerse, Belgium.
GPH is committed to addressing the medical needs of patients in the developing world and resource limited settings. GPH utilizes the resources, capabilities, pharmaceuticals, technologies, access programs, policy initiatives and programs of JRD to positively impact the health and well-being of underserved communities globally. The portfolio consists of projects in HIV treatment, TB treatment and prevention, Non-Tuberculous Mycobacteria treatment, Dengue prevention, Long Acting formulation platform for HIV, TB, Dengue and Malaria.
GPH explores and executes new, more effective collaborations with governments, NGOs (e.g. WHO, MSF), foundations (e.g., B&M Gates Foundation) and academia.
The Medical leader (ML) position will be filled by an individual with extensive experience in pharmaceutical R&D who has demonstrated outstanding leadership, interpersonal and communication skills. The ML should have expertise in infectious diseases and clinical development; expertise and training in epidemiology are also preferred. The ML will support the regulatory dossier development and submission of the Long Acting therapy for HIV and subsequent interactions with the regulatory authorities during the review period and approval process. In addition, the ML will have responsibility of a clinical development plan in Non-Tuberculous Mycobacteria. The latter task will gain increasing importance and become the main responsibility of the position.
This individual will serve as the ML on Compound Development Teams (the core organizational unit of GPH R&D) and will co-lead the Clinical Team for each project. The ML will be responsible for clinical development efforts including study design, protocol development and serve as the responsible study physician of clinical studies in all phases of clinical development. He/ She will also provide scientific input to other projects within GPH based on her/his expertise and training. The ML will collaborate with all other CDT members in determining strategies for health authority interactions, IND/CTA, NDA and other regulatory activities. And will be responsible for interpreting adverse event data from clinical trials, interacting with the Global Medical Safety Organization concerning post-marketing data, and writing and reviewing documents supporting labeling changes.
The ML participates in the preparation of abstracts and manuscripts of clinical research findings for publication and presentations to relevant meetings. He/ She will work with Business Development and participate in due diligence investigations of potential new pharmaceutical licensing and development opportunities. The ML 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.
MD and advanced training in internal medicine and additional advanced training in infectious disease is required.
Subspecialty training in NTM, global public health and epidemiology is highly desirable.
Other requirements include academic experience in clinical research/drug development and at least 5 years of pharmaceutical industry experience in R&D.
The ML should have experience interfacing with early development teams, medical affairs, regulatory affairs and pharmacovigilance organizations.
Previous demonstration of leadership, strong interpersonal and communication skills are essential.
Janssen Pharmaceutica N.V. (7555)
Clinical Research MD