Clinical Project Scientist (CPS) – Associate Director

Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, with a specific focus on the field of Oncology, has a position for a Clinical Project Scientist (CPS) in the Oncology Therapeutic Area. The position will be based out of Europe: Beerse (Belgium), Leiden (The Netherlands) or High Wycombe (UK). The current position is in Late Development (LD) and requires supporting the cilta-cel (a cellular therapy product in the hematologic malignancy space) development program, specifically for support of a phase 2 cancer study in Multiple Myeloma, conducted in China supporting the Study Responsible Physician (SRP). Upon completion of the study the scientist will continue to work on the cilta-cel team’s phase 3 studies. In general, as part of the function, in close collaboration with the SRP and the Molecule Responsible Physician (MRP), the CPS assists in the preparation of protocol writing and operational execution of clinical studies. The CPS participates in the start-up of global clinical studies, ensuring on schedule site activation and subject enrollment, monitoring, compliance with department safety practices, policies, procedures as well as the day to day management of a clinical trial. Furthermore, the CPS will monitor clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and maximize the quality of the study. He or she plays a key role in the medical review of study data and assist in coding, analysis and documentation of Company clinical work. Because this is an assignment on a study conducted in China we are looking for an experienced CPS with a proven track record in working independently across a large time zone difference and with an open mind for cultural differences. Exposure to CAR-T development in the clinical or research setting is highly desirable. Collaboration with safety and data management teams and with the Data Monitoring Committee will be required to make timely decision regarding study objectives. On the longer term, and as part of the phase 3 study development plan, the CPS will help assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication. The CPS will also serve as a liaison between the Company and clinical research staff in many countries. The CPS will participate in the training of site and Company staff on the study protocol, ensure the clinical staff have the necessary guidance and tools for performance of various projects. Furthermore, the CPS This will be working closely with the discovery, biomarkers, clinical pharmacology, companion diagnostic development team, regulatory, statistics and operations. In addition to understanding how these various functions work, the CPS should be capable of implementing translational medicine approaches for late clinical development. The CPS reports directly to the Clinical Research Leader for the product to which he/she is assigned. The position requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards. The successful candidate must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates. The program is in an accelerated development mode and experience with registrations studies will be highly valued. Qualifications This position requires a minimum of an advanced degree in a scientific discipline (i.e. M.S, Ph.D. or Pharm.D. or equivalent). A minimum of 5 years of experience in a CPS position or 9 years in a related clinical research position, spending at least part of the time within the pharmaceutical industry, is preferred. Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important. Good oral and written communication skills are essential. Good presentation skills (including report development) are a plus. Successful work experience in a matrix team environment with cross functional teams is required. A strong commitment to oncology clinical research and the ability to work well within a team setting are essential. Travel may be required and may be up to 15 % annually (international, as well as domestic). Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2206005000W