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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 Director, Clinical Project Scientist in the Oncology Therapeutic Area.
The position will be based out of Los Angeles, CA, Springhouse, PA, Raritan, NJ, High Wycombe, UK or Beerse, Belgium. Other locations such as Germany, Austria, Switzerland, Netherlands, Poland, Hungary, Spain and France will also be considered.
Up to 15% domestic and international travel is required.
The current position is in Late Development (LD) and requires supporting a Late-Development Compound program, specifically running phase 2-3 cancer studies, supporting the Study Responsible Physician (SRP). As part of the role, collaborating with the SRP, the Clinical Project Scientist assists in the preparation of protocol writing for and operational execution of clinical studies. You will participate 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, in this role you will implement clinical study parameters, deliverables, policy compliance and resource needs, apply scientific discipline to minimize risk and increase performance, play a key role in the medical review of study data and timely and high-quality data entry and assist in coding, analysis and documentation of Company clinical work.
The Director, Clinical Project Scientist will participate in investigator meetings, investigator engagement, managing sites to ensure study treatment discontinuation decisions are made per protocol and align with stakeholders within the study team. Work with safety, data management teams and Data Monitoring Committee to make timely decision regarding study objectives. You will assess external clinical research proposals involving Company products and manuscripts that are being prepared for publication. You will also serve as a liaison between the Company and clinical research staff in many countries. Additionally, you 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.
• High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
• 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.
• Require capabilities to work on additional LD studies moving into operation in later years. This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, companion diagnostic development team, regulatory, statistics and operations.
• Understanding how these various functions work, the Clinical Project Scientist should be capable of implementing translational medicine approaches for late clinical development.