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Position Summary / Objective
The Japan Clinical Lead (JCL) serves as the clinical point of accountability for the Japan Development Team and is responsible for the overall Japan clinical development plan for asset(s) in one or more indication(s). JCL ensures studies are aligned with target la bel indications and designed to meet regulatory, quality, medical, and access goals to fit Japan specific requirement/situation. JCL is responsible for implementation, planning, and execution of assigned clinical trial activities, and leads communication with the external stakeholders (e.g. TLs, PI) to efficiently promote responsible clinical program. Accountable for the scientific data evaluation, interpretation and documentation for assigned project development program. For Japan local study, fulfills the CS role defined in Global SOP.
Position Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs within the asset and/or indication
- Accountable for the design, execution, and analyses of each study
- Accountable for clinical content for CSRs and regulatory documents (e.g., briefing books submission documents and regulatory responses)
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Collaborate and serve as primary liaison between external partners for scientific advice
- Serves as Primary Clinical Representative in Regulatory interactions
- Sets executional priorities and partners with CTP and operation team to support executional delivery of studies
- Accountable for top line data with support of CTP and Statisticians
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Evaluate innovative trial designs (collaboration with Japan CTP) • Ensure global clinical study protocol is applicable to local medical practice (manage local protocol amendment, if needed)
- Proactively identifies potential study level risks and drives the execution of mitigation strategies
- Serve as CS in Japan local studies
- o Responsible for implementation, planning, and execution of assigned clinical trial activities
- o Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
- o Co-Leads study team meetings in partnership with Global Trial Manager; and collaborate with cross functional study team members
- o Plan and lead the implementation all study startup/conduct/close-out activities as applicable (collaboration with GTM)
- o Protocol and ICF development process; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Scientific Writing)
- o Site-facing activities such as training and serving as primary contact for clinical questions
- o Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review (collaboration with DM)
- o Clinical data trend identification; provide trends and escalate questions to Japan CTP
- o Develop clinical narrative plan; review clinical narratives
- o Provision of information required by Global Trial Manager for development of trial budget, CRO scope of work, etc.
- o Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Demonstrate leadership as an active member of cross functional teams, task forces, or local and global initiatives
- Effectively influence team and collaborate with senior stakeholders, address complex problems and challenges with positive outlook, able to deliver results with high level professionalism
- Coach the CL in the Clinical Lead work for development of products in Japan from study planning to JNDA filing and thereafter
Degree Requirements
- A minimum of 5 years of clinical development / industry experience preferred
- Expertise in the design, analysis, publication and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader).
- Adequate knowledge of pharmaceutical development process.
- Strong experience in clinical science, clinical research, or equivalent.
- Experience in a matrix team composed of multiple functional organizations.
Experience Requirements
- 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
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development in Japan
- Fluent in spoken and written English for business is preferred
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 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.
Supporting People with Disabilities
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 [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
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: https://careers.bms.com/california-residents/
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R1605081 : Senior Manager, Senior Japan Clinical Lead
