At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Janssen GPH (Global Public Health) utilizes the resources, capabilities, pharmaceuticals, technologies, and programs of Janssen R&D to bring new innovations to 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, COVID-19 and a Long-Acting formulation platform for diverse infectious diseases.

Position summary:

The Clinical Leader (CL) will lead the development and execution of clinical plan for a Ph1/2/3 program in Mycobacterial Diseases. Specifically, the CL is responsible for the clinical development plans, protocol development, quality and timely execution of clinical studies, preparation and ownership of clinical study reports, leading the health authority meetings for clinical/medical issues and for the preparation and approval of crucial documents for regulatory filings. The CL will lead the cross-functional clinical team and will lead direct reports who are project physicians or project scientists. The CL is a critical member in the compound development team (CDT) and will interact with individuals from strategy leader (CDT Leader), clinical operation, project management, regulatory affairs, commercial, legal, quality assurance & compliance, CMC, biostatistics, global medical safety, clinical pharmacology and other scientific and business related fields. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area, as well as supporting external research collaborations.

Essential functions:

• Clinical development plans and has ownership for the design of clinical trials and for the content of clinical study reports


• Interpreting, reports and prepares results of product research in preparation for global health authority submissions


• Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment


• Acting as company medical contact for global health authorities concerning clinical/medical issues


• Assisting Regulatory Affairs in the development of regulatory strategies


• May act as company spokesperson regarding publication or presentation of clinical research findings to relevant global health authorities, advisory committees and externally


• Helping explore and evaluate new ideas while assisting in identifying new scientific opportunities for Janssen GPH


• Supporting general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance


• Participating on and leads teams to acquire external funding and manage research collaborations.


• Responsible for assessing medical publications emerging from the Team and its affiliates;


• Managing budget for all project related clinical activities


• Responsible for managing and mentoring direct reports

Qualifications

Do you meet the Education, Experience and skill requirements below for this orle?

• A Medical Degree or equivalent is required. Appropriate specialization, industry experience, or clinical experience in relevant therapeutic area.


• Experience of Global Public Health is a plus.


• extensive Pharmaceutical Industry Drug Development or related experience is required.


• Experience in the design and conduct of clinical trials is required.


• Global registration experience is an advantage.


• Experience of Collaborative working in a sophisticated reporting line environment.

Do you have the following Technical Knowledge and Skills?

• Solid understanding of the use of Microsoft suite of software products including Excel and Word!


• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation!

Primary Location
United Kingdom-England-High Wycombe-50-100 Holmers Farm Way
Other Locations
Finland, France, Ireland, Belgium, Germany, Spain, Estonia, Portugal, Sweden, United States, Austria, Norway, Czech Republic, Denmark, Italy
Organization
Janssen Cilag Ltd. (7360)
Job Function
R&D
Requisition ID
061120202