Janssen Research & Development Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Clinical Project Scientist - Oncology, Experimental Medicine & Early Development (eMED) preferably located in Spring House, PA or Raritan, NJ.
The Clinical Scientist, Director for Oncology Early Clinical Trials is recruited to work in the Oncology Therapeutic Area Experimental Medicine Early Development (eMED) group on novel anti-cancer compounds in early clinical development. This position will serve as the clinical scientist and study leader for selective programs in oncology Early Development working closely with Study Responsible Physicians and Clinical Leaders in eMED.
The Clinical Scientist, Director has the following essential job functions:
The Clinical Scientist, Director will be 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. She/He will work hand in hand with the ELO 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. The 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 and 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. 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.