◆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