Global Head, Medical Affairs Evidence Generation and Study Execution – Janssen Oncology Global Medical Affairs

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Head, Medical Affairs Evidence Generation and Study Execution-Oncology Global Medical Affairs. This position will be based in Raritan, NJ.

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.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Global Head, Medical Affairs Evidence Generation and Study Execution is responsible for successful execution of global medical affairs studies identified as part of the Worldwide Integrated Evidence Generation Plan (WW IEGP), including Company-sponsored studies, Investigator Initiated Studies (IIS), Collaborative studies, and Cooperative Group studies.  This scope includes interventional, non-interventional and registry studies. 

In this role, the individual will be responsible for leading Medical Affairs Excellence and Study Execution in partnership with the global and regional medical affairs colleagues across the oncology portfolio.  This role will work closely with Global Development (GD) partners, including Medical Affairs Operations (MAO) and Global Clinical Operations (GCO) to manage the execution of these Global Medical Affairs led studies.

Responsibility begins with the WW IEGP annual prioritization and includes supporting global and regional medical affairs teams with facilitation of WW IEGP ideation, development of study proposals, prioritization of study proposals and presentation of study proposals to the WW IEGP committee for consideration.  Oversight continues with study concept approval and includes providing guidance with PED development, study budget creation and protocol drafting, review and approval. Close collaboration with R&D, MAO, GCO, regional colleagues, Global Medical Affairs Scientific Engagement and country MSL teams in site selection and study start-up, planning, and execution will be critical. On-going study tracking, maintenance and reporting will continue until study close out.

This individual will serve as the matrix team leader, partner with the Global Medical Affairs Leader, Study Responsible Physician, Study Responsible Scientist and GD organization to provide medical affairs excellence in study planning, execution, and conduct.

• Collaborate with multiple partners related to planning and strategy for clinical trials and data dissemination.
• Implement innovative internal and external clinical trials within oncology focused on patient diversity, equity and inclusion, healthcare disparities, scientific leadership, clinical trials optimization, external scientific partnerships, and digital partnerships, for example.
• Function as a strategic partner to elevate the contribution and visibility of global medical affairs data generation within and outside of the organization.
• Develop creative and effective solutions to address conflicts, resource constraints and other challenges which may impact clinical trial deliverables.
• Implement real-time monitoring and analysis of impactful metrics that focus on standardizing reporting to aid in decision making and overall strategy
• Monitor Medical Affairs best practices and provide recommendations for process improvement and innovation.

The Global Head, Medical Affairs Evidence Generation and Study Execution will fulfill the following responsibilities:

• In conjunction with the Global Medical Affairs Leader, and Strategy and Execution Leader oversee and support the process for review and tracking of medical affairs clinical trials as part of the WW IEGP
• Serve as the primary liaison between Global Medical Affairs, regional/local Medical Affairs organizations and R&D in the initiation, review and tracking of WW IEGP studies
• Act as the key liaison for our GD partners and other scientific and business-related disciplines (R&D, GMS, QA/QM, Compliance as well as Supply Chain)
• Actively contribute to global strategy, planning and development of a pre-approval access program according to Standard Operating Procedures (SOPs) and Policies
• Collaborate with Global Medical Affairs Lead, Compound Development Team Lead, and regional Medical Directors to develop strategic guidance documents and support WW IEGP studies across the portfolio
• Manage monthly/periodic meetings to monitor and update oversight of WW IEGP studies
• Partner with Global Medical Affairs Leaders and regional Medical Directors in preparing research concepts for internal review committees
• May lead cross-functional teams for evaluating new research concept ideas, implementing evidence generation strategies, and/or developing and monitoring clinical process effectiveness
• Ensure that external insights are considered in the study design/execution and, where appropriate, Steering Committee and other Advisory Committees are implemented
• Improve execution of the WW IEGP program and company-sponsored research through clinical initiatives to improve efficiency (program quality, tracking against financial targets, metrics/ timelines). Initiatives will include support of advisory boards, integrated evidence generation planning process, potential management of internal and external registries