Medical Leader, Respiratory Infections

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.

We are recruiting for a Medical Leader, Respiratory Infections to be located in South San Francisco, CA or Titusville, NJ.

As a Medical Leader, Respiratory Infections you will:

• Provide input on strategy for respiratory compounds to the Respiratory Disease Area Stronghold (DAS)
• Serve on the Compound Development Team (CDT) which owns and maintains the new product Development Compound Strategy documents.
• Give input and feedback on the Clinical Development Plan in alignment with compound and therapeutic area strategy.
• Maintain ongoing compound strategy throughout compound life cycle and manage cross-functional execution of the overall development plan.
• Build and lead a cross functional team in collaboration with the Program Management Leader (PML)
• Serve as the initiator and moderator of the clinical team meetings, developing meeting agendas and co-moderating meetings.
• Lead execution of the Clinical Development Plan and give key input to the Clinical Resource Plan (budgets and FTEs), Medication Plan (clinical project medication needs), Overall Quality Monitoring Plan, Safety Monitoring Plan and Project Essentials & Regulatory Summary Documents.
• Manage/maintain key clinical documents including the Clinical Strategic Plan/Clinical Development Plan, Clinical Trial Protocol, Clinical Study Report, and Clinical Modules of the Common Technical Document.
• Act as subject matter expert for your compound/s
• Oversee the evolution of your project/s to ensure execution within planned timelines and budget.
• Develop and initiate clinical trials including clinical trial protocol development and trial set-up activities including site selection.
• Create supporting documents (Informed Consent, Statistical Analysis Plan, Data Safety Monitoring Board charters).
• Execute clinical trials including meeting with and answering questions of health authorities / IECs / IRBs and conducting investigator meetings.
• Monitor trials, perform medical review and safety analysis including of serious adverse events.
• Review and approve data listings prior to database lock.
• Provide line management for study responsible physicians/scientists or staff assigned to special projects (as applicable).
• Act as a key liaison and support to medical affairs (including publications) and strategic marketing.