Associate Dir Clinical Project Scientist

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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 preferably be based out of Beerse (Belgium), Leiden (The Netherlands) or High Wycombe (UK); or alternatively out of Springhouse (PA, USA) or Raritan (NJ, USA).

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 phase 3 cancer studies in Multiple Myeloma, supporting the Study Responsible Physician (SRP) and the Study Responsible Scientist (SRS). As part of the function, in close collaboration with the SRP and the Molecule Responsible Physician (MRP), t he 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 a novel immunotherapy compound we are looking for a CPS with immunotherapy/cellular therapy experience. Exposure to CAR-T development in the clinical or research setting is highly desirable.
T he CPS will participate in investigator meetings, investigator engagements and the management of sites to ensure study interventions are made per protocol and in alignment with stakeholders within the study team. Collaboration with safety and data management teams and with the Data Monitoring Committee will be required to make timely decision regarding study objectives. 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.
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.
The position will also 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. 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.