Senior Manager, Senior Japan Clinical Lead

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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.

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