Clinical Development Lead (CDL) is responsible for the overall Japan clinical development plan for assigned projects. CDL ensures studies are designed to fit Japan specific requirement and situation from clinical, regulatory, and operational perspectives. CDL is accountable for planning and execution of assigned clinical studies and leads communication with the external stakeholders (e.g. investigators, regulators, KMEs, academic societies). CDL is accountable for clinical contents of local study documents (e.g. protocols, IBs, ICFs) and regulatory documents (e.g. briefing books, responses to regulatory queries, CTDs).
Develops Integrated Development Plan (IDP): accountable for Japan clinical development strategies
Provides RDPT with necessary information including disease landscape, SOC, KMEs and competitor situation in Japan
Works collaboratively with the Project Team and PDC members to integrate the scientific rationale, regulatory requirements, operational feasibility, product development plan, and commercial goals to build a solid strategic framework for the Japanese components of the IDP
Leads clinical development strategy discussion.
Ensure that a Japanese strategic plan is fully aligned with a global strategy and is fully understood by a project team
Leads clinical studies in assigned projects as an owner of the studies.
Ensures the study protocol is applicable to Japanese medical practice and manages local protocol amendment, if necessary.
Ensures that the resources and budget necessary for the successful execution of the trial are secured in collaboration with the CTM.
Accountable for study feasibility in Japan
Accountable for CRO and vendor selection and study budget.
Proactively identifies study level risks and drives execution of risk mitigation strategies
Accountable for solving study related issues in Japan including management of AEs in collaboration with Study Medical Director and Safety Physician.
Maintains study quality
Understands the protocols and educate study team members
Leads medical and scientific discussion as a local clinical representative with investigators and KMEs.
Serves as a local clinical representative in regulatory interactions in Japan
Prepares and/or reviews clinical contents of regulatory submission documents and responses to clinical regulatory inquiries.
Participates in regulatory consultations and discussions
Establishes and maintains scientific reputation in academic societies by participating in major scientific conferences and making scientific presentations/publications.