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 an Associate Director CPS or Director 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 Associate Director CPS / Director CPS executes clinical research strategies, contributes to the development and execution of clinical research programs for company products and ensures the compliance of department, company and regulatory standards and procedures. The function directs study design, protocol development and implementation of clinical studies in the late phase development organization; reviews and evaluates results of phase 2 and 3 investigations in preparation for new drug application to the regulatory agencies. The Associate Director CPS / Director CPS acts as a liaison between company and clinical investigators and develops credible relationships with opinion leaders, medical directors, and key regulatory officials.
The current position is in Late Development (LD) and requires supporting the Daratumumab development program, specifically running a phase 3 cancer study in collaboration with a consortium of Multiple Myeloma centers, supporting the Study Responsible Physician (SRP). As part of the role, collaborating with the SRP and the Molecule Responsible Physician (MRP), the CPS assists in the preparation of protocol writing for and operational execution of this Phase 3 clinical study.
In general 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 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 CPS 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. The CPS will 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; ensures that the clinical staff has the necessary guidance and tools for performance of various projects.
The role 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.
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 8 years of experience 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 but not a requirement. 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).