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.
About the Role
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Major Accountabilities
• CONTRIBUTE TO THE DESIGN AND ANALYSIS OF RWD
o 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)
o Evaluate and assess strengths and weaknesses of external Real World Data sources for
advancing the data strategy for a given therapeutic area.
o 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.
o Ask the right scientific questions, understand the evidence needs and make recommendations
on fit-for-purpose data and analytics solutions.
o 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
Expected background
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 5 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
Why consider Novartis?
817million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス• バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp
Japan
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。
健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
International
Business Unit
Innovative Medicines
Location
Japan
Site
Head Office (Japan) (Pharmaceuticals)
Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No