|新着求人 臨床開発 （MRI-50）|
|募集職種||外資製薬企業の Clinical Leader for Oncology
Position: Major Tasks
• Leads the Clinical Team, a cross-functional team of internal experts, through clinical trials, global product registration, and trials under International clinical marketing plans supporting product life cycle optimization. Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads.
• Member of the J-Project Team representing Oncology clinical development (OCD) and member of the Launch team
• 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 OCD 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.
Education / Experiences / Skills
・University Degree or above
・Qualified Medical Doctor is desired but not a must
・Non-Medical Doctor with Clinical Leader experience (PhD preferred, but fine with MS/BS).
■In-depth understanding of the drug development and commercialization process with a base of experience of 5+ years in Medical Science and drug development (From protocol writing to MRR).
■At least 5 years of clinical practice and academic experience in oncology related are (Board certification is preferred, but not a must)
■Basic knowledge in clinical research, clinical trials, and statistics. Or advanced scientific degree in relevant area (Medical/Clinical/Oncology/etc.) with extensive experience in clinical development at the pharmaceutical industry.
• Excellent English communication skill in English (TOEIC ７３０ or higher), Native level Japanese skill
• Basic PC skill (Microsoft Office）
• Proven leadership, motivational and interpersonal skills
・ Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization
• Must embrace change and be able to work in a changing environment
・Ensuring accountability and consistently achieving results, even under tough circumstances.
・Building partnerships and working collaboratively with others to meet shared objectives.
・Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
・Planning and prioritizing work to meet commitments aligned with organizational goals.
・Seeing ahead to future possibilities and translating them into breakthrough strategies.
・Stepping up to address difficult issues, saying what needs to be said.
・Operating effectively, even when things are not certain or the way forward is not clear.