Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Scientist (Associate Director) Early Development Oncology. The preferred location for this position is Spring House, PA but consideration could be given to other locations (Raritan, NJ and Titusville, NJ, or remote). 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 www.JanssenRnD.com for more information.
The Clinical Scientist (Associate Director) Early Development Oncology works in the Oncology Therapeutic Area Early Development (ED) group and reports to the ED Oncology Clinical Project Scientist.
The Clinical Scientist (Associate Director) has the following essential job functions:
• Scientific responsibilities will include internal activities such as interpreting clinical endpoints for topline results, preparing Clinical Study Reports, and participating in Disease Area Stronghold and Compound Development Team activities. External scientific collaborations will include interacting directly with academic investigators, coordinating clinical presentations at scientific meetings, and facilitating scientific publications in a timely manner.
• As Study Responsible Scientist (SRS), will work together with the Study Responsible Physician (SRP) and GCDO Trial Leader (GTL) in the Core Clinical Team to ensure the efficient initiation and execution of early phase clinical trials.
• Work within the cross-functional ED Clinical Team collaborating closely with the SRP and the ED Project Scientist Leader to plan, execute and oversee patient-oriented oncology ED clinical trials
• Participates in writing protocol synopses, full protocols, informed consent documents, and will help design Case Report Forms (CRFs) and other data collection tools.
• Provide input to the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.
• Lead investigator meetings and site initiation visits.
• Participate in study start-up activities including site selection, review of vendors’ scope of work contracts, timelines, and management of study close out activities.
• For ongoing clinical trials, the SRS will review all incoming clinical data in real time including patient screening results, PK/PD data, adverse events and other study endpoints and will perform medical review activities in collaboration with the SRP.
• Maintain adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines.
• Work closely with other key support areas including Global Clinical Operations, Translational Research, Medical Writing, Regulatory Affairs, Project Management, Biostatistics & Programing, and Clinical Pharmacology, and other allied support functions.
• Provide support to the Global Clinical Operations partners, including the GCDO Trial Leader, Local Trial Manager and Site Managers by working with clinical site staff as needed to resolve issues.
• An advanced degree such as a Master’s degree, Ph.D. or Pharm. D or commensurate exceptional clinical research experience is required.
• A minimum of 3 years of industry experience in Oncology drug development focused on early phase clinical trials is required.
• Significant 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 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.
United States-Pennsylvania-Spring House-
North America-United States
Janssen Research & Development, LLC (6084)
Clinical Research non-MD