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The Early Development (ED) Project Physician Psychosis Spectrum Illness is a responsible member of a clinical team dedicated to the clinical implementation of compounds’ early phase/translational medicine strategy, including. study design, patient selection and precision approaches, endpoints (including novel endpoints), safety evaluation, dose, pharmacology, and pharmacodynamic biomarkers. This may include Phase 0 and experimental medicine studies as well as Phase 1 through Phase 2b studies. The ED Project Physician provides active medical and scientific contribution to a cross-functional discovery, biomarkers and clinical teams, including development and execution of the precision medicine and biomarkers strategy. The ED Project Physician provides input to translational discovery and the clinical development plans, works on the development of the clinical trial protocol, clinical trial materials, oversees and monitors clinical trial execution (including patient safety and data quality) and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include discovery, biomarkers, data science, clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs, clinical supplies unit, medical writing, clinical pharmacology, legal, finance, quality assurance, strategy and operations, global medical affairs, health economics, epidemiology and other scientific and business-related disciplines. The ED Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area
ESSENTIAL FUNCTIONS:
- Responsible for the development and execution of the ED clinical trial protocol(s); ensures quality implementation of study in collaboration with the cross-functional clinical team and CRO/Contractors as needed
- Works closely with discovery, biomarkers, data science and translation teams to align preclinical and clinical biomarker strategies, including the identification and validation of novel endpoints (e.g., biomarkers, intermediate clinical endpoints, digital COAs) to support patient stratification and rapid decision making.
- Close collaboration with Clinical Scientists, Clinical Operations, Medical Monitors, Statistics, Data Management, Biomarkers, Data Science and other functional leaders to ensure data integrity and high-quality trial execution
- Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
- Primary responsible party for Medical Monitoring, including e valuation of adverse events for relationship to treatment
- Responsible for developing and presenting content for Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
- Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
- May act as a medical contact at the company for health authorities concerning clinical/medical issues
OTHER RESPONSIBILITIES / DETAILED DUTIES:
- Assists Regulatory Affairs in the development of drug regulatory strategies
- Executes medical-related consultation for internal stakeholders to ensure unbiased data interpretation
- May help explore and evaluate new assets (BD) and/or products to support compound value, including review of medical literature related new technologies
- Participates in AdBoards & KOL interactions where required (together with / under supervisor of senior clinical personnel)
- Participates in the development of presentations and publications of study results
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
