Medical Leader Tuberculosis Compound
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 (CL), for New TB compound Development.
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 GPH portfolio includes SIRTURO (bedaquiline), the first new drug for the treatment of tuberculosis in 40 years, as well as projects in HIV treatment, Dengue prevention and treatment, and a Long-Acting formulation platform for HIV, TB, Dengue and Malaria.
For the ML position we are looking for someone with significant experience in pharmaceutical R&D who has demonstrated outstanding leadership, interpersonal and communication skills. Expertise in infectious diseases, clinical development and global public health would be an advantage. The principal responsibility is the clinical development plan for New Tuberculosis Compounds progressing from the internal GPH discovery program and in collaboration with external partners and consortia. This individual serves as the medical leader (ML) on Compound Development Teams (the core organizational unit of GPH R&D) and will co-lead the Clinical Team for each project.
If you're interested in this role, the following responsibilities are crucial:
•Responsibility 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. You will also provide scientific input to other projects within GPH based on your expertise and training.
•Collaboration with all other CDT members in determining strategies for health authority interactions, IND/CTA, NDA and other regulatory activities.
•Responsibility interpreting adverse event data from clinical trials, interacting with the Global Medical Safety Organization concerning adverse events associated with compounds in development.
•Participating in the preparation of abstracts and manuscripts of clinical research findings for publication and presentations to relevant meetings.
•Working with Business Development and participate in due diligence investigations of potential new pharmaceutical licensing and development opportunities and be the clinical representative of Janssen on important external collaborations for the co-development of new short regimens for the treatment of tuberculosis.
•Being a subject matter expert in the field by reading the literature, attending appropriate meetings, and participating in appropriate CME courses as needed.
Education and experience•University degree – MD with appropriate specialization, industry experience or clinical experience in relevant therapeutic area.•At least 5 years of clinical or research leadership experience•Experience in the design and conduct of phase I, II and III clinical trials•Pharmaceutical Industry experience in drug development (e.g. Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics, Clinical Pharmacology, Study Responsible Physician)•Experience in functioning in a team structure including a Matrix structure
Preferred knowledge•Therapeutic domain knowledge•Working knowledge of guidelines and applicable SOPs regarding the development of new chemical entities and the conduct and medical supervision of clinical trials•Computer literacy
What’s in it for you…?“Caring for the world, one person at a time…”As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)