■The candidate must be able to provide critical scientific/ clinical pharmacology input in support of the execution of early development clinical studies that contribute to the product development and global strategic plans across different therapeutic areas.
■The candidate will be responsible for interpreting and reporting clinical trial data, preparing clinical pharmacology sections in J-CTD/NDA, responding to queries from regulatory agencies and participating in discussions with these groups as it relates to clinical pharmacology/ early development.
■The candidate will be expected to identify and maintain relationships with key external collaborators while providing strategic and scientific/ clinical pharmacology input into commercialization activities and product lifecycle management.
|応募資格||* Postgraduate Clinical Pharmacology training
* At least 5 years of drug development experience with expertise in early clinical development
* Knowledge of regulatory requirements for early clinical development/ clinical pharmacology studies
* Experience interacting with regulatory agencies, in particular PMDA
* Ability to identify and solve problems while exhibiting superior judgment and a balanced, realistic understanding of issues
* Experience with authoring regulatory documents
* Ability to work effectively on cross-functional teams
* Excellent interpersonal skills
* Excellent oral and written communication skills