336346BR
Jan 31, 2022
Japan

Job Description

Purpose:
-Oversees all operational aspects of clinical trials (clinical pharmacology studies and PoC studies) end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. -Complete oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial.

Major accountabilities:
-Is a global clinical lead or country / cluster leader responsible for clinical program(s)
-Responsible for the planning, executing and implementation of operational strategy of assigned clinical trial(s),
-Develops materials for trial
-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations
-Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas
-Contributes to the global initiatives (e.g., process improvement, training, SOP development, other line function initiatives)
-Contributes to talent and career development of associates through on-boarding, coaching, and/or mentoring support

Key performance indicators:
-Excellence in execution and implementation of clinical operations strategy
-Timely, efficient and quality execution of assigned trial and trial related activities within budget, and in compliance with quality standards.
-Proactive operational planning with effective contingency and risk mitigation plans.
-Cost effective management of budget and resources with limited unforeseen cost overruns.

Through operational excellence in early phase studies, can contribute to earlier decision making, and/or earlier treatment availability to patients not only in Japan but worldwide.
Can experience dynamic science and build operational excellence through the operation of assigned early phase trials.

このポジションでは卓越した早期臨床試験のオペレーションを通じて、より早期の決断を可能にし、日本だけではなく世界中の患者がより早期に治療を受けることに貢献できます。
また担当する早期臨床試験を通じて、ダイナミックな科学に触れることができ、卓越したオペレーション能力を身につけることができます。

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

Areas of experience:
People Leadership Organization Scope; Scale and Complexity People Challenges

Skills & Knowledge:
Trial Planning and Feasibility Clinical Trial Set-up, Management & Conduct Regulatory Strategy

Languages: Fluency in English and Japanese
NIBR
Translational Medicine
Japan
Tokyo
Research & Development
Full Time
Regular
No
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336346BR

Head, Clinical Science & Innov Japan

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