メディカル・バイオ - メディカルアフェアーズ

■Summary
RWE and Evidence excellence is responsible for providing strategic oversight and guidance as well as operational support on observational research/ real-world data & evidence initiatives that are pursued by internal teams, such as the Medical Affairs teams. The incumbent must have deep knowledge and extensive experience with Real-world Data (RWD) and Observational Research (OR)/ RWE generation, to partner with the Head of Medical Franchises, HEOR and GDD to lead the co-Integrated Evidence Plan (IEP) at Novartis, and to provide expert guidance and direction to internal teams on local IEP planning, study delivery, strategic data acquisition and building of internal RWE capabilities.

■Major Accountabilities
・CONTRIBUTE TO THE DESIGN AND ANALYSIS OF RWD
◦ Co-lead Data generation planning, implementing and delivering high quality, scientifically robust observational and/or Clinical trials design (i.e. target population, protocol development,sample sizing)

◦ Evaluate and assess strengths and weaknesses of external Real World Data sources for advancing the data strategy for a given therapeutic area.

◦ Design a fit-for-purpose analysis plan, assess effective ways of delivering the results to maximize impact and interpretability

・RECOMMEND DATA SOLUTIONS to address evidence needs.
◦ Ask the right scientific questions, understand the evidence needs and make recommendations on fit-for-purpose data and analytics solutions.
◦ Leverage RWD and technology to propose solutions for enhancing medical practice and patient outcomes (e.g. engagement platforms, TPO dashboard etc.)
・Co-Lead the integrated evidence plan in collaboration with Medical Head /
・Effectively facilitate thoughtful planning, tracking and executing stages for RWE projects to ensure fit-for-purpose solution design, implementation.
・Lead to build Local Real World evidence generation capability and expertise
・Hold the accountability for tracking IIT progress (time/cost/quality) to drive the effective IIT delivery as per the agreed evidence plans in collaboration with MGL
・Guarantee Good Clinical Practices (GCP) and internal procedures compliance in collaboration with MGL.
・Build an internal global-regional-local network to share best practices
・ Manage SRB Office and act as SRB Reviewer
・Act as Other SUD Reviewer
・ Act as RWE center of excellence core member
・ Act as TPO champion

■Key Performance Indicators
・Accelerate the SUD first culture (ratio SUD/PDC)
・Achievement of target patient outcomes
・Time, cost, quality and impact of evidence generation
・Continuous improvement of RWE talent pool

■休日：完全週休二日制, 土, 日, 祝日

■Education:
• Bachelor’s degree, Advanced science degree (MD, PhD, PharmD, MPH etc) strongly preferred

■Languages:
• Fluent in Japanese and English (business level) Experience/Professional requirement:
• More than 3 years of experience in the pharmaceutical industry, CRO/consulting firms or academic institute with broad and deep knowledge of RWE activities with a proven successful track record of RWE scientific publications in peer-review journals.

■Competency
• Deep understanding of Medical Affairs or Market Access/ HEOR, Safety or related disciplines to generate value evidence from retrospective and prospective studies.
• Deep understanding of available and emerging RWD data sources in Japan.
• Considerable experience in planning, creation, and analysis of real-world data, from both prospective and retrospective studies
• Demonstrated ability to engage a complex matrix of internal and external stakeholders to identify and articulate evidence needs and gaps and define RWE plans to address them.
• Logical, critical thinking and strong problem-solving skills

■職種未経験者：可