Study Responsible Physician

Study Responsible Physician (m/f/x, 100%) Location: Beerse, Belgium; Leiden, Netherlands; Bern, Switzerland; various locations in US. Other locations also may be considered. At Janssen everything we do is engineered with the patient in mind. It drives us to search for new ideas and innovative healthcare solutions. We embrace challenges and develop treatments that will change the lives of our patients. Janssen Vaccines & Prevention B.V., part 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 About you: An enthusiastic team player with a Medical degree. Solid experience in clinical development of vaccines. Ideally with an experience in global clinical development and accustomed to working in a global team. Proactive, good communicator, and a quick learner. Fluent in English. Being part of Johnson & Johnson can change everything, including YOU: You will be rewarded through a competitive remuneration package along with continuous training, support and award-winning leadership development programs. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Netherlands-South Holland-Leiden- Other Locations North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House Organization Janssen Vaccines & Prevention BV (8852) Job Function R&D Requisition ID 2105996707W