メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

The Clinical Scientist (CS) in Japan is the single point accountability for the development of the Clinical Development Plan (CDP), study design, governance and interpretation of results of the studies, and filing strategy and key messages in CTD (clinical modules) for Japan. The study design is expected to fulfil a strategic objective of the clinical development to maximize the asset values for Japan.
The CS will have accountability for approximately 2 projects (assets) at any one time and they will be required to work collaboratively alongside Japan Development, Japan Regulatory Affairs and Japan Medical Affairs colleagues, as well as with global Medicines/Vaccines Development Team (MDT/VDT) and Clinical Sciences members to drive the ongoing success of the projects
Key Responsibilities
• Single clinical development voice at the both program level & study level in Japan MDT/ VDT, Japan Early Development Team (J-EDT), and other cross-functional collaboration with Japan Medical Affairs, GAMA, Japan Commercial functions, etc.
• Lead Japan clinical development with global and local clinical leaders such as the Clinical Development Lead (CDL), Clinical Science Lead (CSL), Clinical Sciences members, Study Delivery Lead (SDL) and Local Delivery Lead (LDL). Serves as the program and study level point-of-contact in Japan.
• Lead scientific interactions with external stakeholders (e.g. regulators, EEs, investigators), and work closely and collaboratively with CDL and CSL to input Japanese requirements and co-create integrated global development plan to maximize the asset values.
• Update and deliver Clinical Development Plan (CDP).
• Develop study (e.g. Protocol, main ICF, CTN (scientific contents)) & regulatory documents (e.g. CTD, briefing documents for consultation, and answers to queries from Regulatory authority).
• Study Design: Develop study design with CSL and clinical sciences members, including integrated input from internal/external experts, and patients in Japan.
• Scientific Oversight for the Study: Respond to scientific questions arising from sites in Japan to secure the quality of study during study conduct. Ensure that study analysis plan for Japan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.
• Evidence Outputs: In terms of Japan analyses, interpret study data to create the scientific content of Clinical Study Report (CSR) and prepare the abstracts, posters and presentations for scientific meetings, congresses, external journal publications.

■休日：完全週休二日制, 年末年始

• MD certificate.
• Scientific, medical and regulatory knowledge including disease, treatment and guidelines.
• Strategic assessment and decision making skills for designing clinical development plans and clinical studies.
• Ability to interface with relevant scientific external stakeholders (e.g. regulators, EEs, CROs, investigators) to deliver clinical studies.
• Creative thinking skills for developing innovative business solutions.
• Solid understanding of clinical research and biostatistics principles to facilitate innovative and efficient clinical trial design with clear data-driven decision rules.
• Ability to use judgment, statistics, and visualization techniques to analyze and interpret moderately complex information.
• Ability to lead scientific interactions and respond confidently to complex questions using sound judgment.
• Knowledge about the importance of work undertaken in support of the medicine/vaccine vision and lifecycle management plan.
• Experience contributing to projects and working collaboratively with multiple stakeholders.
• Ability to research and use data from various sources to make robust fact-based decisions, employing diverse and critical thinking.
• High-level English and native-level Japanese communication skills.

■職種未経験者：不可