Company OverviewGlobal Pharmaceutical company
Job Description• Leads the Clinical Team, across functional team of internal experts, through clinical trials,global product registration. Sets project-related objectives with team members. Requests
clinical team members and clarifies resource availability with functional heads.
• Member of the JPT (Japan Project Team) representing Oncology-Clinical development and member of the Launch team, representing Oncology-CND
• In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved
CDP. Proactively initiates corrective action as needed.
• Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and
initiates actions or decisions as appropriate.
• In consultation with the Head of the Oncology-CND and Global Clinical Leader/Global Development Lead, is responsible for communication of medical project and study strategy,
study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations, and presents them together with
the Program Leader to the Japan Medical & Development Committee.
• Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical
leader/ Global Development Lead, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators’ Brochures (IB).
• Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the TA-MAF the publication strategy. Ensures
consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail.
Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.
• Provides medical assessment of in- and out-licensing opportunities of development projects
• Provides domestic study concepts to ensure compliance with global strategy
• Coaches clinical leaders, clinical project managers and medical experts on their tasks and ensures aligned and consistent scientific/clinical contents across indications and products which target a similar disease area under the guidance of the Function Head.