The Director, Real World Evidence (RWE) Team Leader is responsible for driving high priority real world evidence research projects from early strategy development through to execution and completion. This newly created role will be critical for effectively and efficiently moving into a new area of research that involves the establishment of critical new processes for partnering with healthcare delivery system/data provider organizations for prospective clinical research purposes.
Key to success will be to develop expertise working with electronic health records for research purposes and partnering with academic and research institutions. The Team Leader will partner closely with key Janssen stakeholder organizations such as Strategic Marketing, Medical Affairs, Epidemiology, IT and Clinical Operations. Additional key partners will include Commercial Excellence, Communications, Regulatory, Legal, HCC, Privacy, Procurement, Finance and potentially others.
Responsibilities
Leads the development and maintenance of Real World Evidence (RWE) studies from within Janssen Scientific Affairs and across Asia Pacific Pharmaceuticals and Janssen.
Manages successful cross-functional execution of the RWE studies through negotiating with functional heads about deliverables.
Aligns the team to achieve its goals through the networks of people/functions represented on the team
Identifies issues and leads contingency planning.
Leads problem-solving and provides decision-making tools and techniques to make RWE studies successful.
Leads the communication of strategy and plans for RWE studies within and outside JSA.
Leads introduction of new RWE capabilities to Janssen AP, particularly related to Randomized Pragmatic Trials, but also to other RWE-related activities.
Where applicable, work with Health Authorities to align on research strategies
Work across Janssen AP, Global Janssen and J&J to establish leadership in RWE and manage multiple studies and complexities associated with the introduction of innovative RWE capabilities.
Help to shape the broader Janssen AP RWE strategy, capability building & implementation efforts.
Act as a company spokesperson regarding publication of real world evidence research findings, including presentations to relevant health authorities as well as to external professional organization scientific meetings
Additionally
Leads cross-functional Janssen teams to execute real world evidence studies together with Janssen stakeholder organizations.
Collaborates with external healthcare delivery system/data provider organizations on execution of high value studies.
Becomes an internally and externally recognized expert in the strategy and execution of real world evidence studies through attending and participating in external scientific meetings and producing high-value publications.
Develops future leaders in the real world evidence research space.
Performs other work related duties as assigned.
Qualifications
PhD/MD/PharmD required.
A minimum of 7-10 years total experience required. A minimum of 5+ years of experience in Medical Affairs, R&D or Health Economics Outcomes Research or equivalent required.
Experience with real world evidence projects desirable, including working with electronic health records.
Experience working in or collaborating with healthcare delivery systems, data provider organizations and/or payer environment highly preferred.
Proven track record in cross-functional team leadership required.
Flexible self-starter with excellent networking and team building capabilities.
Ability to balance multiple and complex tasks, and effectively perform in a matrixed environment.
Advanced knowledge of Word, PowerPoint, Excel required.
Familiarity with regulatory and healthcare compliance guidelines/policies desired.
Demonstration of competencies for creativity, problem-solving, and innovative solutions desired.
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