Senior Director, Pediatric Clinical Development - Milvexian

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director, Pediatric Clinical Development - Milvexian , to be located in Raritan, NJ .  Remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Clinical Leader (CL) is responsible for the development and execution of the pediatric development program for Milvexian. including operational implementation, delivered through effective leadership of a cross-functional Clinical Team (CT).  The CL leads the team to deliver trial(s) in a timely and cost-effective manner according to the pediatric investigational plan (PIP), protocol(s) development, execution, preparation, and ownership 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. Team leadership via matrix interactions also includes individuals from project management, operations, 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 scientific opportunities in the therapeutic area.

ESSENTIAL FUNCTIONS:

• Recruitment, supervision, and development of clinical staff assuring diversity of candidates
• Responsible for pediatric clinical development plans and has ownership for the design of clinical trials and for the content of clinical study reports
• Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions
• Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment
• Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting
• Acts as medical contact at company for worldwide health authorities concerning clinical/medical issues
• Assists Regulatory Affairs in the development of drug/device regulatory strategies
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• May support early clinical development and discovery activities involving product potential and development for registration
• Participates on evaluation of new product ideas, implement franchise business strategies, etc.
• Responsible for assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion
• Ensures the study is executed within a budget for all project related clinical activities