YOUR TASKS AND RESPONSIBILITIES

• Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, global product registration, and ICMP trials 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 TA-Clinical Development and member of the Launch team, representing TA Clinical Development

• 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 Therapeutic Area (TA) and Global Clinical leader, 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 Project Leader to the Japan Development Management 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, 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

WHO YOU ARE

• University Degree or above

• MD Preferred but not a must

• Non MD: In-depth understanding of the drug development and commercialization process with a base of experience of 5+ years in Clinical Development  (From protocol writing to CSR)

• MD: 5 or more years clinical experience in cardiology or nephrology TA is preferred 

• Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization

Thrombosis & Nephrology Incumbent must embrace change and be able to work in a changing environment

• Cardiology & Nephrology TA Experience is preferred but other TAs will also be considered

• Proven leadership, motivational and interpersonal skills

• Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,

• Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively

• Fluent in Japanese language (including writing skill), and Business English skill (TOEIC 730 or above)

HOW TO APPLY

Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
Please find other working conditions at our career site, by coping and pasting the following URL on your internet browser.
https://career.bayer.jp/en/working-at-bayer/professionals/treatment

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