Director, Project Responsible Physician - Neuropsychiatry

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include 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 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 clinical trial protocol(s); ensures implementation of study in collaboration with the cross-functional clinical team and CRO/Contractors as needed.

• Close collaboration with Clinical Scientists, Clinical Operations, Medical Monitors, Statistics, Data Management 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 evaluation 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.

• May be responsible, with appropriate colleagues, for review of Clinical Trial company advertising and promotional materials.