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Senior Manager, Japan Clinical Lead

Senior Manager, Japan Clinical Lead

Bristol Myers SquibbJP,Otemachi
19 days ago
Job description

Description

  • 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

Required Capability

  • 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
  • Preferred :

    • MD / PhD / PharmD 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 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.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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    Senior Manager Japan • JP,Otemachi