募集要項
- 募集背景
- A multinational pharmaceutical company is looking to hire a Clinical Operation Leader. In this role you will be responsible for the conduct and oversight of clinical programs, leading strategic planning for clinical development programs in Japan.
- 仕事内容
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A multinational pharmaceutical company is looking to hire a Clinical Operation Leader to conduct and oversee clinical development programs in Japan.Responsibilities:
* Develop clinical synopsis, protocols and amendments, investigator brochures, and clinical study reports with global clinical development
* Lead the clinical study team and provide appropriate monitoring for clinical studies including CRO oversight
* Evaluate pharmacology, safety, and efficacy data from ongoing and completed studies
* Conduct literature reviews and prepare summaries to support clinical development programs
* Be a resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines
* Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility
* Interact with key opinion leaders related to assigned compounds and therapeutic areas
* Contribute to JNDA, NDA, and MAA filings and prepare relevant sections of the regulatory documents
Requirements:
* 2+ years' experience in clinical development
* Strong leadership skills and the ability to work cross-functionally
* Excellent communication, interpersonal, and negotiation skills
* Knowledge of FDA, EMA, PMDA, and other regulatory requirements
* Ability to travel both domestically and internationally as required
- 応募資格
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- 必須
- 2+ years' experience in clinical development
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY12,000,000.00 per annum
- 休日休暇
- 英語力必要。その他は詳細からご確認ください。