Study Delivery Lead

14時間前


Minato 711 GlaxoSmithKline K.K. Full time

Job Purpose and Key Responsibilities

We are seeking a highly skilled and experienced professional to lead our clinical trials from planning to completion.

This role will be responsible for managing the study team, ensuring timely and quality delivery, and maintaining accountability for budget, timeline, and quality.

  • Develop strategic plans for Japanese development, participating in feasibility assessments, risk evaluation, and budgeting.
  • Operate clinical trials, including specific policy decisions (at various study levels), stakeholder management, participant registration strategies, CRO oversight, study-level inquiries, monitoring report approvals, budget/timeline/study risk management.

This position is also responsible for general organizational operations and staff development, including collaboration with SDL/LDL teams, improving in-house operational capabilities, and organization development.

Required Skills, Experience, etc.

Basic Qualifications

Skills/Knowledge:

  • Leading matrix teams
  • Study management skills
  • Stakeholder management and communication skills (building good relationships with internal and external stakeholders)
  • Quality/process control skills
  • Problem-solving skills
  • Decision-making skills
  • Management skills (business/achievement management, risk management, human resource development/organization development)
  • Negotiation skills
  • Agility (ability to adapt to changing environments)
  • Japanese pharmaceutical development-related regulatory affairs

Experience:

  • At least 3 years of experience in clinical trial operation and study management
  • Experience in study management for outsourced studies by CRO
  • Membership in project teams composed of representatives from various departments, with experience leading team activities
  • Creating clinical trial protocols and informed consent documents

Education/Certification/Language:

  • Bachelor's or higher degree in medicine, pharmacy, veterinary medicine, life sciences, etc.
  • English language proficiency (TOEIC 800 points or above) sufficient to communicate with foreign colleagues without obstruction

Desired Qualifications

Skill:

  • Ability to collect and evaluate necessary information for development strategy formulation from an operational perspective

Experience:

  • Experience in operating and managing oncology trials (especially Phase I)

Education/Certification/Language:

  • Master's or Ph.D. degree in medicine, pharmacy, veterinary medicine, life sciences, etc.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.



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