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新着求人 メディカルドクター  (MD-20)
募集職種 外資系製薬企業の Japan Development Team Lead, Oncology
勤務地 東京
会社概要 非公開
求人要件 Main roles are to oversee the entire clinical development program for each indication or each asset, and lead cross functional team, and to consider the Japan strategy for each indications from initiation of clinical development to approval in Japan
【Position Summary / Objective】
• Has the accountability of the development strategy for an asset or assets in one or more tumor types
• As a responsible person in assigned projects, demonstrates strong leadership to execute development plans aligned with therapeutic area strategy and timeline with high standard of quality.
• Engages and collaborates with global counterpart to align with global strategy as a representative of ** in assigned therapeutic area or new products.
• Provide input to senior leadership team for effective decision-making and execution.
【Position Responsibilities】
• Provide Matrix leadership to create the overall development strategy for an asset or assets in one or more tumor types with other functions
• Creates and ensures execution of the overall clinical development plan for an asset or assets in one or more tumor types. Solicits and integrates input from statistics, regulatory, outcomes research, medical, commercial and other experts. Ensures that studies are aligned with target label indications and commercial goals, and are properly designed and conducted in a timely and cost efficient manner.
• Oversees the review of safety and efficacy data across the program and integrates this information in order to detect relevant patterns and makes study modifications or start/stop recommendations as needed. Provides timely updates to governance boards.
• Lead filing activities as cross functional leader
• Responsible for the creation of key study documents (e.g., integrated summaries of safety and efficacy for Japan specific protocol, briefing documents for health authority interaction etc.).
• Initiates, develops and maintains key relationships with internal and external stakeholders.
• Has accountability for filing strategy and responsibility for considering regulatory strategy (e.g. JPI and Japan HA interaction strategy etc.) with regulatory strategy lead
• Selects, leads, develops, motivates and achieves results through teams.
• Provides Matrix leadership for integrated team of professionals who are responsible for all components of study design and execution. • Oversees Phase 1 – Phase 3 studies
必要要件 • MD/PhD/PharmD/MS preferred
Experience Requirements
• A minimum of 5 years of clinical development / industry experience preferred
Key Competency Requirements
• Facilitate and lead conversation in English preferred
• Expertise in design, execution, analysis and publication of Phase I-III clinical trials
• Experience with clinical components of regulatory submissions and clinical presentations to regulatory authorities
• Overseeing Phase 1 – Phase 3 studies, with demonstrated decision making capabilities
• Broad, in-depth knowledge of clinical, regulatory science, and medical science within assigned therapeutic area
• Expertise in using the scientific method to test hypotheses, including study design, analysis, and interpretation
• Knowledge of the drug development process
• Strong leadership skills with proven ability to lead and work effectively in a team environment
Travel Required
• Travel to domestic or international sites or conference to be required as needed
年収 能力、経験を考慮の上、当社規程により優遇 
募集背景 非公開 
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