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

【Job Purpose】
• The Japan Clinical Operations Asset Lead (J-COAL) represents all Clinical Operations functions at the asset level in Japan and is responsible for developing the operational strategy and delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with Global COAL. J-COAL works closely with clinical / biostats and the functional subject matter experts in Japan to ensure informed asset decision-making from the operational, scientific and data perspectives. Key Responsibilities
• Contribute to the development of the Integrated Clinical Development Plan and Integrated Evidence Plan, during Research, Development and Life Cycle Management phases of the asset lifecycle. To achieve this, become a single point of contact for Global COAL.
• Resourcing strategy:
• Lead resourcing discussions in Japan, being responsible on final strategy (in vs outsourcing) for the asset, and studies, in accordance with the resourcing strategy & principles.
• Responsible for Japan input to Global COAL on assessment, selection, contracting and management of appropriate vendors for outsourced clinical activities and services, ensuring compliance with GSK standards.
• Oversight of delivery quality:
• Lead escalation point from study and asset level to raise and assist with issues on behalf of the team, including serious quality incidents and serious breaches of GCP.
• Responsible for the coordination and leadership of cross-functional team input into development plans, ensuring quality delivery of all studies included within the plans.
• For outsourced programs, oversight to ensure the quality delivery.
• Delivery plan:
• Drives innovative approaches to study execution through external facing advances in technology and sciences, by identifying and embracing risks and opportunity
Responsible for asset delivery strategy (e.g. country, diversity, patient engagement strategies etc) in collaboration with cross-functional stakeholders, with particular focus for Clinical Operations contributions to governance boards.
• Responsible for budget forecasts for clinical studies and Clinical Operations asset level costs, ensuring they are accurately represented and managed in financial tools.
• Asset level risk register, communication, and systems data
• Ensure asset level operational risk management plan is in-place and applies a smart-risk taking philosophy.
• Responsible for asset level mitigation plans are implemented to avoid and manage risk/quality issues.
• Responsible for translating the technical content of the TMP/TVP/IEP to ensure appropriate operational implementation at the study level.

■休日：完全週休二日制, 年末年始

【必要な条件Basic Qualification】
■スキル Skill
•Demonstrate strategic thinking, an enterprise view, collaborative working skills, and matrix management capabilities with an inclusive mindset
•Understanding of pharmaceutical ethics, governance, compliance policies and proceduresa
•Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary
•Strong influencing and stakeholder management skills
•Creative thinker - able to modernise approach to study delivery
•Effective problem solving and conflict resolution skills with a solutions-oriented mindset
•Appropriate project management skills
•Develop a proactive response for preventing critical issues in programs / studies
•Verbal and interpersonal skills in both English and Japanese 経験 Experience
•8 years’ extensive experience in managing clinical development projects or equivalent with a proven track record of successful project/study delivery in the pharmaceutical industry, and demonstration of leadership
•Strong knowledge and experience in clinical operations and matrix management 学位/資格/語学力 Education/certification/Language
•Masters or equivalent expertise in relevant scientific discipline (e.g. life science, medical, pharmacy)
•Business level English

【望ましい条件 Preferred Qualification】
■経験 Experience
•Demonstrate experience in multicultural settings and diverse environments with respect to dynamics of human interaction including working with remote teams
•Respiratory or/and Immunology experience 学位/資格/語学力 Education/certification/Language
•PharmD/PhD/MD
•Business level Japanese

■職種未経験者：不可