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.
-
Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose & Key Responsibilities: · The successful candidate will be responsible for planning and executing clinical trials from start to finish, ensuring timely delivery, quality, and budget accountability. For local studies, this involves leading the Study Delivery Lead (SDL) ...
-
Study Delivery Lead
14時間前
Minato 711 GlaxoSmithKline K.K. Full timeJob 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 accounta ...
-
Minato Universal Beijing Resort IT私たちがDigital Transformationで目指すもの · 世界中からますます注目を集め、さらなる発展が予想される大阪ベイエリア。 · 国内外から多くのゲストがUSJ、そして大阪というDestinationを訪れられます。 · その中で、ゲストの体験価値をより豊かなものにするため、パーク来場前・来場中・来場後とシームレスなデジタル体験を提供すべく、ダイナミックかつ革新的なDXを目指しています。 · 米国本社とのプロジェクト協働でもあり、困難なチャレンジも少なくないですが、他では味わえない貴重な体験・キャリアを得られる機会です。 · 私たちと ...
-
VEO Expert
3日前
Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose & Key Responsibilities · The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP) & Integrated Evidence Plan (IEP) in Japan for the assigned products. With thorough evaluation, the VEO Expert cross-functionally leads, coordinates, plans, imple ...
-
Minato 711 GlaxoSmithKline K.K. Full timeJob Title: CPMS Asia/Japan Lead · The CPMS Asia/Japan Lead will provide technical therapeutic, and product development support for GlaxoSmithKline projects. · About the Role: · Ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Model Inform ...
-
Scientific Affairs Lead
14時間前
Minato 711 GlaxoSmithKline K.K. Full timeJob Title: Medical Strategy Lead · About the Role: · Collaborate with cross-functional teams to develop a global medical strategy that addresses unmet medical needs in various regions. · Support the growth and development of local Medical Science Liaison (MSL) networks, ensuring ...
-
Minato Universal Beijing Resort ITTechnical Lead, Application Delivery - USJ · The Technical Lead, Application Delivery - USJ will be responsible for driving initiatives, providing leadership and oversight of architecture deliverables across USJ digital transformation. · This role requires strong experience with ...
-
Specialist – Marcom
14時間前
Minato Ansell Full timeThe Specialist – Marcom Fairs & Events Support, JAPAN Medical role supports and manages various marketing projects within the JAPAN Medical business unit. The incumbent activates JAPAN Medical's marketing strategy to achieve financial targets outlined in the operating plan. · Key ...
-
Minato JP007 Oliver Wyman Group Kk Full timeJob Description · Description: · Nera Economic Consulting is a global firm of experts dedicated to applying economics, finance and quantitative principles to complex business and legal challenges. · For over 60 years, Nera's economists have been creating strategies, studies, repo ...
-
Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose & Key Responsibilities · The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery of differentiated medicines of value for patients, stakeholders, and markets in Japan. The J-MDL serves as the asset level point- ...
-
MSL(Oncology)
14時間前
Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose · The Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to the MSL Head. · In order to build trust with External Experts (EE) and the scientific community, the MSL needs to play a role as an external facing ...
-
Service Manager
14時間前
Minato Entegris Full timeJob Title: · Tech Leadership for Japan and Korea Service · Job Overview: · This technical leadership role offers tremendous visibility within the company, leading service delivery in Japan and Korea to address customers' most challenging problems and identify new opportunities. T ...
-
Minato CiscoJob Title: Customer Experience Manager · As a Customer Experience Manager, you will play a pivotal role in driving the successful adoption and utilization of Cisco technologies and services within customer organizations, leading to value realization and growth of our business. · ...
-
Japan Lead
14時間前
Minato 711 GlaxoSmithKline K.K. Full timeGSK is a global biopharma company seeking a Japan Site Lead (WREF & EHS) to manage facilities, environment, health and safety, and security services for GSK Japan offices. The successful candidate will oversee real estate and facility management, ensuring infrastructure supports ...
-
Minato 711 GlaxoSmithKline K.K. Full timeJob Purpose: · Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code of ...
-
Minato Disney Experiences PermanentJob Title: Creative Operations Associate Manager for Asia Pacific · The role of the Creative Operations Associate Manager for Asia Pacific involves overseeing operational tasks across the creative outputs of the APAC Creative team. Based in Japan, this position will focus on supp ...
-
Minato American ExpressYou Lead the Way. We've Got Your Back. · With the right backing, people and businesses have the power to progress in incredible ways. When you're part of our global community at American Express, you'll learn and grow as we help you create a career journey that's unique and meani ...
-
Minato Universal Beijing Resort ITDynamic Digital Transformation Project · The Osaka Bay Area is attracting increasing attention from around the world, driving further development. · With many guests visiting from Japan and abroad, we aim to enhance guest experience value through dynamic and innovative digital tr ...
-
Minato CiscoCustomer Experience Manager · We are seeking a seasoned Customer Experience Manager to drive the successful adoption and utilization of Cisco technologies and services within our customer organizations, leading to value realization and growth of our business. · You will be the pr ...
-
Minato The Walt Disney Company (APAC) RegularJob Title: Disney+ Brand Marketing Lead · Job Summary: We are seeking a skilled and experienced marketing professional to lead our Disney+ brand marketing efforts in Japan. The successful candidate will be responsible for formulating communication strategies, developing and execu ...
-
Minato Entegris Full timeJob Title: · Field Applications Engineer · Description: · The Field Applications Engineer is a critical member of the Instrumentation Sales & Applications team, responsible for supporting local Equipment and System providers to Samsung. · Key Responsibilities: · Technical Service ...