Director Clinical Project Scientist

Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Scientist (Director) Early Development Oncology. The preferred location for this position is Spring House, PA, but consideration could be given to other locations. Up to 25% travel may be 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) 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 (Director) has the following essential job functions: Scientific responsibilities will include internal activities such as interpreting clinical endpoints for topline results, participating in preparing Clinical Study Reports and 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 for 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 and execute 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. Review CRFs during development and prior to finalization throughout the clinical trial to ensure the CRF is appropriate and captures data in alignment with the protocol. Provide input to the Statistical Analysis Plan, the Data Management Plan, and the Safety Management Plan. Prepare the Medical Review Plan, review with the SRP and finalize. Lead investigator meetings and site initiation visits (SIV), including the development of training materials. Participate in pre-trial assessment visits (PTAV) as needed. 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. Reviews will be documented in medical review forms and in iDARTs; and issues will be discussed with the SRP as needed. For clinical trials including Safety Evaluation Team (SET) meetings, will develop the SET charter, lead the SET kickoff meeting and provide training on SET to the investigators. For each SET meeting, will prepare timelines for completion of data entry and query resolution, data extraction, preparation of data output and presentation to the SET in collaboration with the cross-functional ED Clinical Team. With the SRP, will co-lead the SET meeting presentation and prepare meeting minutes to document outcome. 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 & Programming, and Clinical Pharmacology, CAR-T Apheresis and Site Liaisons (CASLs) and other allied support functions. 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. Participate in preparation for and presentations for Janssen governance reviews. Contribute to preparation and review of documents supporting regulatory submissions. Provide support to the Global Clinical Operations partners, including the GCDO Trial Leader, Local Trial Manager and Site Managers by working with the clinical site staff as needed to resolve issues Qualifications A Master’s Degree, Ph.D., Pharm.D., or a B.A./B.S. with commensurate exceptional clinical research experience is required. A minimum of 8 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. Excellent oral and written communication skills, the ability to work in a team environment, and adherence to the highest personal and ethical standards with a dedication 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. Eradicate Cancer Primary Location United States-Pennsylvania-Spring House-Welsh & McKean Roads Other Locations North America-United States-New Jersey-Raritan Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206034635W