Johnson & Johnson Careers
Clinical Scientist Early Development Oncology
Beerse, Belgium; Spain; France; Leiden, Netherlands
Clinical Research non-MD
Requisition ID: 1805673524W
Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Scientist (Junior Director) Early Development Oncology. The preferred location for this position is Beerse Belgium but consideration could be given to other locations. Up to 15% travel is required.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Clinical Scientist Early Development Oncology works in the Oncology Therapeutic Area Early Development (eMED) group. He/she reports to an ED Clinical Scientist Director. The position will participate in reviewing the scope of work for central labs, central ECG and other vendors, and will liaise with GCDO in study start up process including budgets and contracts, compliance with country/site regulations and SOPs.
This position will be responsible for reporting clinical study milestones including study starts, database locks, and topline results to the Clinical Scientist. Operational duties may include ensuring compliance with Good Clinical Practice guidelines and working directly with local trial managers and site monitor for smaller trials, or with the broader Global Clinical Operations group to execute early phase clinical studies.
The Clinical Scientist ED Oncology has the following essential job functions:
Participate in drafting protocol synopses, full protocols, informed consent documents, and will review Case Report Forms (CRFs) and other data collection tools against draft protocols and central lab vendor scope of work.
He/She will work together with the Clinical scientist to mitigate issues in initiation of early phase clinical trials and may participate in review of Monitoring Guidelines, SET charter, the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.
He/She will liaise with Translational Research (pharmacokinetic operations & biomarker operations) to ensure sample collection, processing and tracking.
He/She will liaise with Integrated Data Analysis & Reporting in set-up of data visualization tools (eg, iDARTs).
For ongoing clinical trials, this individual will participate in preliminary review of clinical data in real time including patient screening results, PK/PD data, adverse events and other study endpoints.
Work within the cross-functional Early Development Clinical Team to plan, execute and oversee patient-oriented early phase clinical trials.
Collaborate closely with the Clinical Scientist in the execution of oncology ED clinical trials.
May participate in training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study.
May participate in drafting documents for Health Care Authority interactions
An advanced degree such as a Master’s degree, Ph.D. or Pharm. Degree or with commensurate clinical research experience is required.
Knowledge of basic and translational research with an understanding of applications to cancer drug development is required.
The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research are essential is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Europe/Middle East/Africa-France, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Spain
Janssen Pharmaceutica N.V. (7555)
Clinical Research non-MD