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The Clinical Leader (CL) is responsible for leading the team for a number of Milvexian level activities across all LIBREXIA clinical trials (IDMC, CEC etc.) and milvexian safety oversight across the program along with supporting other functional program needs. They will lead the Operational Alignment and Safety Integration Strategy Team (OASIS) for the LIBREXIA program within the CVMRPH Therapeutic Area. They will support the preparation of the compound and trial level documents, such as the Development Safety Update Report, Investigator Brochure, and Health Authorities and Ethics Committees/Institutional Review Board responses. In this role they may serve as Molecular Responsible Physician.
The CL will lead their team to oversee and support the compound level safety and operational harmonization work across clinical trials, support the Independent Data Monitoring activities, the Joint Safety Monitoring Team and the emergency hotline service, Clinical Events Committee, development, and updates of the Clinical Development Plan within Compound Development Plan. They will contribute to protocol development, preparation of clinical study reports, and for the preparation and approval of essential documents for regulatory filings. The CL may manage direct reports who are project physicians. They will operate in a matrix environment including external partners, and interact with different functions including project management, operations planning, project direction, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business-related disciplines. The CL is also expected to assist in the leadership of the evaluation of external scientific opportunities in the therapeutic area.
Major Duties & Responsibilities