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Position Summary
This role will lead the RCO Japan, Clinical Operations team and is responsible for execution excellence in operational planning, implementation, trial management, site management and monitoring of clinical trials (registrational, non registrational / Investigator Sponsored Research (ISR)) conducted within Japan. This leadership role will serve as a member of the RCO Japan or global RCO Leadership Team and be part of the GDO extended leadership team. This role will also serve as a member of the local R&D leadership team managed by Head R&D. This role will interact with the development teams, local medical and key BMS stakeholders in order to ensure effective management of Japan conducted clinical trials.
This role will support a GDO quality culture collaborating with both the GDO Global Clinical Compliance team as well as the GQ Clinical Trial and Safety group.
Duties/Responsibilities
- 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.
Reporting Relationship
- Direct line reporting responsibility for CT Monitor, CTM, CTA, Vendor Operations, Site Contract Lead, Country Coordinator and Late Development Trial Manager roles.
- Report to direct/dotted supervisor; Head R&D Japan / Head Global RCO, GDO
Key Stakeholders/Contacts:
- RCO Team Japan
- Global Development Operations
- Global Quality Clinical Trial and Safety Group
- BMS Clinical Development, Project Management, BDS, GRS, PS, Medical, Commercial, Human Resources, Legal and Compliance
- Local clinical trial sites
- Contract Research Organizations (CRO)
- Local authorities (PMDA etc.) and other external organizations.
Qualifications, Skills & Experience
Core Qualifications
- 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
Key Skills
- 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
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through scienceâ„¢ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records