This job has expired, please see additional jobs below
Clinical Scientist, Director for Oncology Early Clinical Trials
Johnson & Johnson
Spring House, PA, United States
Job Details - this job has expired, please see similar jobs below
Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Scientist, Director for Oncology Early Clinical Trials located in Spring House, PA, Raritan, NJ or Titusville, NJ with 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, Director for Oncology Early Clinical Trials works in the Oncology Therapeutic Area Experimental Medicine Early Development (eMED) group. He/she reports to the eMED Project Scientist Leader. This position will review the scope of work for central labs, central ECG and other vendors, and will oversee the study start up process including budgets and contracts, compliance with country/site regulations and SOPs.
The Clinical Scientist, Director will assist in site selection and will lead investigator meetings/site initiation visits. For ongoing clinical trials, this individual 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.
Essential job functions include:
• Work within the cross-functional Early Development Clinical Team to plan, execute and oversee patient-oriented early phase clinical trials.
• Collaborate closely with the Study Responsible Physician (SRP) and the Project Scientist Leader in eMED in the execution of oncology ED clinical trials.
• Function as the Study Leader or Co-Leader for early phase clinical trials working in close collaboration with the SRP in overseeing all study initiation and study conduct activities for the TA
• Ensure the efficient collection and review of safety, efficacy, PK/PD, and proof-of-concept data for early phase clinical trials while maintaining adherence to 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 scientific leadership internally for the conduct and interpretation of early phase trials and externally in academic collaborations and scientific presentations and publications directly related to trial outcomes
• Responsible for writing protocol synopses and core elements, informed consent documents, and will help oversee the generation of full protocols, Case Report Forms (CRFs) and other data collection tools.
• Will work hand in hand with the Project Scientist Leader and ED GCO team to ensure the efficient initiation of early phase clinical trials and will provide input to the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan.
• When serving as Study Leader, this position will be responsible for the timely delivery of clinical study milestones including study starts, database locks, and topline results.
• 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.
• 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.
Qualifications
• A Master’s Degree, Ph.D., Pharm.D. or with commensurate exceptional Clinical Research experience is required.
• A minimum of 8 years of industry experience in Oncology drug development, early phase clinical trials and clinical operations is required.
• Significant knowledge of basic and translational research and an understanding of applications to cancer drug development are required.
• Excellent oral and written communication skills, 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 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.