Clinical Trial Lead (Oncology Early Phase)

Company Overview
This pharma is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.

Our medicines reach more than 250 million people worldwide.

Job Description
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.

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

Additional Job Information
主に末期のがん患者さんが参加する抗がん剤Ph1試験にかかわり、治療困難ながんに対して、最先端科学が立ち向かう最初の臨床ステージに立つことになります。Globalと協働しながら、世界と同時期でのFirst in Human試験の計画・実施や、サイエンスをドライブしていくことに興味のある方、ぜひご応募ください！

• 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。

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