※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
A non-clinical expert to manage non-clinical programs including toxicology and pharmacology designed to evaluate compounds in the company's pipeline.
An ability to work independently in a fast paced, dynamic and changing environment is essential.
Design and management of multiple simultaneous toxicology studies in rodents, non-rodents (e.g. dogs and rabbits) and non-human primates is required. Studies will be conducted exclusively at contract research organizations, and experience in collaborative CRO vendor relationships is essential.
Must have working knowledge of key regulatory guidance documents and the filing of reports with regulatory agencies in the Japan (in collaboration with key regulatory personnel), and experience in writing and submission of regulatory documents. Support for processes related to compound registration is also essential.
This position will manage every aspect of the study process, including budget, execution and troubleshooting, data analysis, and report writing.
Membership and effective contributions to multidisciplinary project teams is required. As required, this position may be a member of or make presentations to senior level management committees such as Research Steering Committee and/or Development and Commercial Steering Committee.
This position will also be responsible for participation on multiple business diligence/due diligence and external collaborations, experience in evaluating business development opportunities from safety and nonclinical perspective is highly preferred.
- At least 5 years' experience in the pharmaceutical or device business, preferably with biologics
- Experience in development of non-clinical study package (especially, toxicology) to ensure compliance with regulations.
- Experience designing and managing studies at contract research organizations.
- Writing and interpreting non-clinical data, including the development of CTD, briefing documents for PMDA consultation meeting, responses to PMDA and non-clinical study reports
- Exposure to bioanalytic procedures and sample evaluation
- Experience in preparing toxicological risk assessments.
- Preparation and submission of regulatory documents
- CRO monitoring and qualification
- Non-clinical study and budget management, management of professional personnel.
- Development of new supportive technologies. Experience with novel delivery systems and surgical technique helpful
- Exposure to key principles of lab animal and vivarium management helpful
- Excellent written and verbal communication skills
- Experience working within a matrix working environment and a displayed willingness to support global initiatives that influence the working environment at company in a positive way (e.g. participation in multidisciplinary workstreams
※Experiences and skills will be considered
1st Interview: Medical Writing Head and HR
2nd Interview: R&D Head/ VP, HR Senior Manager
Final Interview: Non-Clinical Head in overseas
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.