Global Originator Pharmaceutical Company
- As Local Clinical Program Leader you assume responsibility for preparing the Japanese clinical development plan for projects in the indication area Immunology from start of development to registration
- You work in close collaboration with other local and global Medicine functions to prepare a local input that reflects the Japanese patients' needs, maximize the value of local academic knowhow and is aligned with the global development strategy and recognized by company's global medicine
- You are accountable for the strategic planning, oversight and execution of the program in Japan. Ensuring that all projects are correctly managed in both timelines and quality
- With your expertise and scientific insight, you lead the regulatory strategy, ensuring successful submission and approval as clinical development lead
- You ensure that development product has a positive benefit risk, justifying development in Japan
- You present and defend the project to internal decision committees as well as to external stakeholders, e.g. regulatory authorities and external experts
- In your new role you are expected to establish strong network with Japanese external experts. In addition, to transfer knowledge internally to other relevant business functions
- Medical degree or PhD in life sciences with clinical and/or research experience in dermatology, rheumatology, immunology or relevant specialty
- At least 3 years' experience in pharmaceutical industry in clinical development or medical affairs role
- Preferably prior experience with submission of documents to regulatory agencies in Japan
- Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams
- Agile and effective working style in a fast-paced and changing environment
- Fluent in Japanese and English with very good communication and presentation competencies
- Willing to work in a global environment
12 Million yen ~ 14 Million yen
(Experiences and skills will be considered)
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