Senior Director, Head of Clinical Operations, Japan
Bristol-Myers Squibb
Senior Director, Head of Clinical Operations, Japan
Job Description
Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives, utilizing global best practices. Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration. Executes clinical trials, as per the RCO Japan Book of Work. Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met. Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data. Endorses country and site feasibility targets for RCO Japan. Manages the RCO Japan team's workload and support of multiple studies. Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities. Takes a broad business perspective when making decisions. Makes judgements to ensure work is achieved within target timelines. Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities. Builds and maintains a highly performing team of highly qualified, Japan based, research professionals and the respective line managers. Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff. Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan. Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing. Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients. Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders. Identify, maintain and optimally grow clinical investigative site/institution/network relationships through direct/personal and/or group engagements in most impactful manner. Supports a GDO quality culture. Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations. Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field. Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context. Ability to lead large, diverse teams and navigate complex organizational structures. Deep understanding of ICH-GCP, local regulations, and global procedural documents. Experience in operational planning, resource allocation, and risk management at a regional level. Multiple years (10-15+ years) industry experience or equivalent Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integration Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are met. Strong focus on governance, CAPA, metrics, and fostering a quality culture across teams. Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomes. Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teams. Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial execution. Fluent Japanese/English verbal and written communication for global communication
Key Responsibilities
- Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives
- Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration
- Executes clinical trials as per the RCO Japan Book of Work
- Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met
- Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data
- Endorses country and site feasibility targets for RCO Japan
- Manages the RCO Japan team's workload and support of multiple studies
- Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities
- Takes a broad business perspective when making decisions
- Makes judgments to ensure work is achieved within target timelines
- Exercises sound judgment in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities
- Builds and maintains a highly performing team of highly qualified, Japan-based research professionals and the respective line managers
- Manages the hiring, development, coaching, mentoring, performance management, and succession planning of staff
- Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan
- Meets or exceeds project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing
- Develops, maintains, and maximizes strong working relationships with peers, senior leaders, key stakeholders, and external institutions/networks to influence decisions and achieve optimal results focused on patients
- Drives alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders
- Identifies, maintains, and optimally grows clinical investigative site/institution/network relationships through direct/personal and/or group engagements in the most impactful manner
- Supports a GDO quality culture
- Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations
Required Qualifications
- Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field
- Multiple years (10-15+ years) industry experience or equivalent
- Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context
- Deep understanding of ICH-GCP, local regulations, and global procedural documents
- Experience in operational planning, resource allocation, and risk management at a regional level
- Fluent Japanese/English verbal and written communication for global communication
Skills Required
- Ability to lead large, diverse teams and navigate complex organizational structures
- Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integration
- Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are met
- Strong focus on governance, CAPA, metrics, and fostering a quality culture across teams
- Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomes
- Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teams
- Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial execution
Locations
- Otemachi, Japan
Salary
Estimated Salary Rangemedium confidence
250,000 - 400,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to lead large, diverse teams and navigate complex organizational structuresintermediate
- Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integrationintermediate
- Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are metintermediate
- Strong focus on governance, CAPA, metrics, and fostering a quality culture across teamsintermediate
- Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomesintermediate
- Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teamsintermediate
- Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial executionintermediate
Required Qualifications
- Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field (experience)
- Multiple years (10-15+ years) industry experience or equivalent (experience)
- Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context (experience)
- Deep understanding of ICH-GCP, local regulations, and global procedural documents (experience)
- Experience in operational planning, resource allocation, and risk management at a regional level (experience)
- Fluent Japanese/English verbal and written communication for global communication (experience)
Responsibilities
- Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives
- Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration
- Executes clinical trials as per the RCO Japan Book of Work
- Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met
- Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data
- Endorses country and site feasibility targets for RCO Japan
- Manages the RCO Japan team's workload and support of multiple studies
- Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities
- Takes a broad business perspective when making decisions
- Makes judgments to ensure work is achieved within target timelines
- Exercises sound judgment in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities
- Builds and maintains a highly performing team of highly qualified, Japan-based research professionals and the respective line managers
- Manages the hiring, development, coaching, mentoring, performance management, and succession planning of staff
- Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan
- Meets or exceeds project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing
- Develops, maintains, and maximizes strong working relationships with peers, senior leaders, key stakeholders, and external institutions/networks to influence decisions and achieve optimal results focused on patients
- Drives alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders
- Identifies, maintains, and optimally grows clinical investigative site/institution/network relationships through direct/personal and/or group engagements in the most impactful manner
- Supports a GDO quality culture
- Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations
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Answer 10 quick questions to check your fit for Senior Director, Head of Clinical Operations, Japan @ Bristol-Myers Squibb.
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Senior Director, Head of Clinical Operations, Japan
Bristol-Myers Squibb
Senior Director, Head of Clinical Operations, Japan
Job Description
Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives, utilizing global best practices. Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration. Executes clinical trials, as per the RCO Japan Book of Work. Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met. Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data. Endorses country and site feasibility targets for RCO Japan. Manages the RCO Japan team's workload and support of multiple studies. Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities. Takes a broad business perspective when making decisions. Makes judgements to ensure work is achieved within target timelines. Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities. Builds and maintains a highly performing team of highly qualified, Japan based, research professionals and the respective line managers. Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff. Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan. Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing. Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients. Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders. Identify, maintain and optimally grow clinical investigative site/institution/network relationships through direct/personal and/or group engagements in most impactful manner. Supports a GDO quality culture. Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations. Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field. Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context. Ability to lead large, diverse teams and navigate complex organizational structures. Deep understanding of ICH-GCP, local regulations, and global procedural documents. Experience in operational planning, resource allocation, and risk management at a regional level. Multiple years (10-15+ years) industry experience or equivalent Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integration Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are met. Strong focus on governance, CAPA, metrics, and fostering a quality culture across teams. Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomes. Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teams. Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial execution. Fluent Japanese/English verbal and written communication for global communication
Key Responsibilities
- Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives
- Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration
- Executes clinical trials as per the RCO Japan Book of Work
- Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met
- Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data
- Endorses country and site feasibility targets for RCO Japan
- Manages the RCO Japan team's workload and support of multiple studies
- Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities
- Takes a broad business perspective when making decisions
- Makes judgments to ensure work is achieved within target timelines
- Exercises sound judgment in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities
- Builds and maintains a highly performing team of highly qualified, Japan-based research professionals and the respective line managers
- Manages the hiring, development, coaching, mentoring, performance management, and succession planning of staff
- Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan
- Meets or exceeds project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing
- Develops, maintains, and maximizes strong working relationships with peers, senior leaders, key stakeholders, and external institutions/networks to influence decisions and achieve optimal results focused on patients
- Drives alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders
- Identifies, maintains, and optimally grows clinical investigative site/institution/network relationships through direct/personal and/or group engagements in the most impactful manner
- Supports a GDO quality culture
- Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations
Required Qualifications
- Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field
- Multiple years (10-15+ years) industry experience or equivalent
- Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context
- Deep understanding of ICH-GCP, local regulations, and global procedural documents
- Experience in operational planning, resource allocation, and risk management at a regional level
- Fluent Japanese/English verbal and written communication for global communication
Skills Required
- Ability to lead large, diverse teams and navigate complex organizational structures
- Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integration
- Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are met
- Strong focus on governance, CAPA, metrics, and fostering a quality culture across teams
- Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomes
- Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teams
- Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial execution
Locations
- Otemachi, Japan
Salary
Estimated Salary Rangemedium confidence
250,000 - 400,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to lead large, diverse teams and navigate complex organizational structuresintermediate
- Ability to act as a strategic change agent, driving organizational agility and efficiency through process optimization and technology integrationintermediate
- Expertise in trial feasibility, site selection, and execution excellence, ensuring timelines for study start-up, recruitment, and database lock are metintermediate
- Strong focus on governance, CAPA, metrics, and fostering a quality culture across teamsintermediate
- Ability to build and maintain relationships with internal leadership teams, external institutions, and clinical trial sites to influence decisions and optimize outcomesintermediate
- Proven capability in hiring, coaching, mentoring, performance management, and succession planning for large teamsintermediate
- Skilled in aligning with global development operations, medical, regulatory, and commercial teams to ensure seamless trial executionintermediate
Required Qualifications
- Advanced degree, preferably in life sciences, pharmacy, medicine, or a related field (experience)
- Multiple years (10-15+ years) industry experience or equivalent (experience)
- Proven track record in managing end-to-end clinical trial delivery (registrational and non-registrational) within a global or regional context (experience)
- Deep understanding of ICH-GCP, local regulations, and global procedural documents (experience)
- Experience in operational planning, resource allocation, and risk management at a regional level (experience)
- Fluent Japanese/English verbal and written communication for global communication (experience)
Responsibilities
- Demonstrates strong leadership and resilience by inspiring team engagement, driving performance, and effectively steering teams through organizational changes and transformation initiatives
- Acts as a strategic change agent leader, adeptly navigating complex matrix structures and executing change management initiatives to achieve organizational objectives through effective cross-collaboration
- Executes clinical trials as per the RCO Japan Book of Work
- Ensures timely study-start-up and that target subject recruitment numbers and database lock timelines are met
- Proactively evaluates clinical trial feasibility and site selection by collaborating cross-functionally to evaluate current metrics and data
- Endorses country and site feasibility targets for RCO Japan
- Manages the RCO Japan team's workload and support of multiple studies
- Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities
- Takes a broad business perspective when making decisions
- Makes judgments to ensure work is achieved within target timelines
- Exercises sound judgment in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities
- Builds and maintains a highly performing team of highly qualified, Japan-based research professionals and the respective line managers
- Manages the hiring, development, coaching, mentoring, performance management, and succession planning of staff
- Ensures effective utilization of FSP resources in the execution of clinical trials conducted in Japan
- Meets or exceeds project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing
- Develops, maintains, and maximizes strong working relationships with peers, senior leaders, key stakeholders, and external institutions/networks to influence decisions and achieve optimal results focused on patients
- Drives alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders
- Identifies, maintains, and optimally grows clinical investigative site/institution/network relationships through direct/personal and/or group engagements in the most impactful manner
- Supports a GDO quality culture
- Ensures a continuous improvement, collaborative mindset across the R&D organization and Global Clinical Operations
Tags & Categories
Answer 10 quick questions to check your fit for Senior Director, Head of Clinical Operations, Japan @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs