Janssen Vaccines &Prevention B.V., one of the JanssenPharmaceutical Companies of Johnson & Johnson, is dedicated to bringingtransformational vaccines to the world to prevent and treat some of the mostlife-threatening infectious diseases of our time.
Our teams focus on thediscovery, development, manufacture and marketing of vaccines to protect peopleworldwide from infectious diseases.
The Clinical Developmentdepartment is responsible for the design, scientific execution, review andinterpretation of results and reporting of all global clinical trials run byJanssen Vaccines & Prevention.
Youwill join a team of Physicians and Scientists reporting into the Medical Leador the Clinical Franchise Lead.
Janssen Vaccines & Prevention has repeatedly stepped up torespond to emerging infectious disease threats like the Ebola and Zika virusoutbreaks.
We are now running a highly accelerated development plan for avaccine targeting SARS-CoV-2, the cause of the ongoing pandemic.
We areurgently looking for a motivated and seasoned vaccine clinical developmentexpert to join our Emerging Infectious Diseases Franchise and assume leadershipof the clinical development for this vaccine.
The Study Responsible Physician (SRP) is a member of the cross-functionaltrial team and the clinical team. The SRP contributes to the design of thetrial including writing the Clinical Trial Protocol and is closely involved in studyinitiation related activities from the scientific point of view together withthe Operational Leader of the study.
This includes for example site selection,CRO selection, setting up a Data Monitoring Committee, participating in thesafety management team and review of the eCRF and other data collection toolsand training of site staff and monitors and vendors.
During the study the SRPis responsible for the medical review and other medical / scientific questionsrelated to inclusion and exclusion criteria and trial conduct.
At the end ofthe study the SRP is involved in the activities related to database lockfollowed by the presentation of the results, preparing the Clinical StudyReport and writing of abstracts / manuscripts.
The SRP may also be involved in Advisory Boards, creation of theInvestigator Brochure, creation of regulatory submission documents and couldact as a support in Medical Affairs related activities.
In addition, the SRPcould contribute to the development and improvement of departmental proceduresand processes and templates in the scope of the company’s effort towardscontinuous quality improvement.
We are looking for an enthusiastic team player with a medical degree. Theperfect candidate will have experience in global clinical development, is accustomedto working in a global team and has experience in clinical development ofvaccines and scientifically inclined.
In addition, candidates should beproactive, good communicators, and quick learners.
Theteam is looking forward to seeing your application.
Europe / Middle East / Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)