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Integrated Data Analytics & Reporting, Therapeutic Area Lead
Requisition ID: 00001CMV
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring an Integrated Data Analytics & Reporting, Therapeutic Area Lead to be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, UK.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Integrated Data Analytics & Reporting (IDAR), Therapeutic Area Lead is accountable for the overall strategy associated with IDAR deliverables within the assigned therapeutic area, in close collaboration with the Portfolio Delivery Operation Heads. This strategy includes traditional IDAR deliverable approaches, use/creation of standards and templates, utilization of tools and platforms, functional sourcing decisions, risk-management approaches and optimal dataflow to support real-time data availability
Interacts within and outside IDAR, in close collaboration with the Portfolio Delivery Operation Heads, to ensure execution of the IDAR strategy, proper prioritization and alignment across IDAR, for their assigned therapeutic area. This includes:
- Leading the cross-functional IDAR team and ensures alignment of IDAR leads.
- Responsible for the cross-functional IDAR strategy and deliverables: establish and build strong relationships within IDAR and with GCDO, QS and other relevant stakeholders Reviews resource planning, prioritization, and allocation to ensure optimal support.
- Accountable for ensuring IDAR expertise and responsibility to deal with conflicts in priority setting and related resourcing for assigned area.
- Maintains a complete overview for the portfolio and IDAR’s critical path activities for assigned area. Maintains overview of sourcing strategies applied to area, vendors utilized within area and budgets associated with deliverables
- Ensures IDAR operational issues/challenges are proactively identified and addressed through operational risk mitigation, including proposals for alternative solutions and escalation. Communicate trends in issues/challenges.
- Participates in establishing the strategy and direction of IDAR within GCDO and contributes to strengthening IDAR capabilities.
- A minimum of a Bachelor’s degree is required. An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred
- A minimum of 10 years of experience in a leadership function in clinical operations is required
- Expert knowledge is required in at least one of the following areas: data management, programming, risk management, central monitoring, medical writing
- A minimum of 5 years of project management and/or functional management is required
- Specific experience in a Therapeutic Area and strong portfolio knowledge is required
- A good understanding of data management/ risk management, central monitoring/programming/medical writing practices is preferred
- Good knowledge of regulatory guidance documents such as ICH requirements is required
- Demonstrated leadership and decision-making skills are required
- Demonstrated interpersonal skills to build relationships, act as a change agent, and adapt to rapidly changing organizational & business challenges is required
- Demonstrated innovative thinking to allow for optimal execution of clinical development strategies is required
- Demonstrated experience managing and monitoring cross-functional teams as a trusted and inclusive leader, and proven experience working on multi-disciplinary teams is required
- This position may require up to 20% domestic and international travel
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)