Oncology Japan Development Team Lead for Early Compound
As a responsible person in assigned assets , demonstrates strong leadership to execute development plans aligned
- Oncology Japan Development Team Lead for Early Compound
- (High-level Description; including manage team/individuals or not) ・ As a responsible person in assigned assets (Oncology Early Compound), demonstrates strong leadership to execute development plans aligned with therapeutic area strategy and timeline with high standard of quality. ・Oversights team’s activities to ensure quality of execution. ・ Provide input to senior leadership team for effective decision-making and execution. ・Engage and collaborates with global/alliance counterpart to align with Japan strategy as a representative of in assigned therapeutic area. ・Provide input to senior leadership team for effective decision-making and execution. ・ Reports to Head of Oncology development. 役割 (Roles & responsibilities) ・Leads the JEDT and JFDT for the Heads of Oncology Development in Japan ・People development and management ・Creates and ensures execution of the overall clinical development plan for an asset or assets in one or more tumour 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 the Head of Oncology Development in Japan and governance boards. ・Responsible for the creation of key study documents (e.g., integrated summaries of safety and efficacy). ・Initiates, develops and maintains key relationships with internal and external stakeholders. ・Selects, leads, develops, motivates and achieves results through teams. ・Provides Matrix leadership for integrated team of professionals who are accountable for all components of study design and execution. ・Oversees Phase 1 - Phase 2 studies ・Provides medical and scientific expertise to colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments. Provides scientific/medical input to, and reviews various study plans which are implemented by the Operations group. Advises creative solutions for operational obstacles. Provides medical/scientific perspective regarding pricing, reimbursement, quality of life, publications needed at launch, lifecycle management etc. in order to achieve the program’s commercial objectives.
- ・MD/PhD/PharmD preferred ・A minimum of 5 years of clinical development / industry experience preferred ・Expertise in design, execution, analysis and publication of Phase II-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 both clinical and medical science within assigned therapeutic area ・Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation. ・Knowledge of the drug development process. ・Knowledge of the components needed for an effective clinical plan and protocols. ・Strong leadership skills with proven ability to lead and work effectively in a team environment.
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- 1960 年
- 許可番号 13-ユ-302907
- 県知事認可法人 許可番号