340473BR
Apr 28, 2022
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

• 非臨床から臨床に導入する初期の臨床開発段階からの世界同時開発を推進するため、First in human試験(TCO trial)に確実に日本から参加することを基本戦略とします。
• Japan Clinical Trial Leadは、日本における計画を立案、準備、遂行するなど、日本のstudy teamをけん引することで、上記目標を達成します。

Your Responsibilities:
・Lead the clinical trial protocol development/translation for local and global trials in collaboration with global Early Project Team (EPT) as well as Japan Project Team (JPT) in Japan
・Lead the start-up activities of clinical trials; preparation of clinical trial-related documents such as informed consent forms (ICFs), Investigators Brochures (IBs), etc.; handling the scientific aspects of regulatory processes, such as development of “Scientific Rationale” document of Clinical Trial Notification (CTN), responses to scientific questions from health authorities, etc.
・Build and manage effective working relationship with key investigators to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication. Lead protocol training meetings and support CPOs when conducting regional trials.
・Lead Local Trial Team (LTT) members to adhere to the global standards of performance and quality. Chair LTT meetings, report study progresses and issues with a resolution plan. Manage trial-level interactions with monitoring teams and other relevant functions when necessary.
・Contribute to functional center of excellence in clinical trial execution by developing and/or improving process standards and tools to achieve excellence in trial operations and management.

What you’ll bring to the role:
・Conducting TCO trials scientifically, safely and successfully, not just securing full compliance to the relevant regulations and internal rules but also with integrity.
・Well managing LTT and other key internal stakeholders, resulting in the on-time delivery of high quality clinical trial data and data analyses which enable strategic decisions to be made in a timely manner
・Communicating effectively with investigators, resulting in Novartis being regarded by external parties as the credible, ethical and preferred partner
・Conducting TCO trials in alignment with planned trial timeline and budget.
・Contributing to operational excellence and/or attractive working place.

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


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Desirable Requirements:
・Fluent Japanese (oral and written) Good English (oral and written)
・+4 years technical, operational and management experiences in planning, executing, reporting and publishing clinical studies in pharmaceutical company or contract research organization.
・Experiences in oncology early clinical development preferred
・Good knowledge of Good Clinical Practice, clinical trial design, and drug development processes including regulatory processes.
・Good communication and team management skills
NIBR
TCO NIBR
Japan
Tokyo
Research & Development
Full Time
Regular
No
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340473BR

Japan Clinical Trial Lead

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