Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing transformational vaccines to the world to prevent and treat some of the most life-threatening infectious diseases of our time. Our teams focus on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
The Clinical Development department is responsible for the design, scientific execution, review, and interpretation of results and reporting of all global clinical trials run by Janssen Vaccines & Prevention. You will join a team of Physicians and Scientists reporting into the Medical Lead or the Clinical Franchise Lead.Responsibilities and Duties
The Study Responsible Physician (SRP) is a member of the cross-functional trial team and the clinical team. The SRP contributes to the design of the trial including writing the Clinical Trial Protocol and is closely involved in study initiation related activities from the scientific point of view together with the Operational Leader of the study. This includes for example site selection, CRO selection, setting up a Data Monitoring Committee, participating in the safety management team, and review of the eCRF and other data collection tools and training of site staff and monitors and vendors. During the study, the SRP is responsible for the medical review and other medical/scientific questions related to inclusion and exclusion criteria and trial conduct. At the end of the study, the SRP is involved in the activities related to database lock followed by the presentation of the results, preparing the Clinical Study Report, and writing of abstracts/manuscripts.
The SRP may also be involved in Advisory Boards, creation of the Investigator Brochure, creation of regulatory submission documents and could act as a support in Medical Affairs related activities. In addition, the SRP could contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement.Qualifications
In addition, candidates should be proactive, good communicators, and quick learners.
The team is looking forward to seeing your application!
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 a 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 the accommodation.Primary Location