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Position Summary
The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.
Duties/Responsibilities
Medical Monitoring
- Conducts medical data review of trial data, including eligibility review
- Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
- Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
- Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
- The range of CTP's medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
- Japan CTP could be expected to take a primary CTP role for local initiated trials or program
- In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
- Provides oversight and medical accountability for a group of studies
- Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
- Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
- Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
- Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist
Qualifications
Education/Experience/ Licenses/Certifications:
- MD is required, Ph.D. is highly recommended
- Deep/extensive knowledge on all over clinical development that is equivalent to 5-10 year-experiences
- Broad knowledge on full process of pharmaceutical development and its regulatory guidance/guidelines
- Ability to propose and execute improvement and innovation in TA and cross-TA works
- Skills of budget planning and resource management
- Good communication skills in both Japanese and English
- Strong leadership qualities with the ability to create a culture of collaboration and teamwork that fosters open communication, constructive conflict, and organizational flexibility
- Excellent interpersonal skills, with the ability to build relationships, act as a change agent, and adapt to rapidly changing organizational and business issues
- Broad and in-depth understanding of domestic and international issues relative to the industry
- Experience to assure business compliance and control within the compliance obligations, Sarbanes Oxley and other audit requirements
- Expertise in the components needed to execute an effective clinical plan and protocols
- Ability to deliver the outcomes under the ambiguity or complexity
- Ability to partner with people at all levels of the organization
- Ability for proactive proposal building and proactive action takings without detailed instructions
- Ability to respond flexibly to the changing project/task priorities and work assignments.
- Ability to influence and negotiate without specific authority.
- Ability to take a risk and to manage it without jeopardizing quality and/or compliance
- Ability to build action plans based on the organization vision
- Acts to makes a balance between short-term performance and long-term vision.
- Fluent in spoken and written English & Japanese for business is preferred
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , 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 . Visit 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, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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