非臨床 毒性研究 -製薬会社

お問合せ Eureka Teramura
参照 JO-2010-449376
about Eureka Teramura

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 「世界で最も革新的な企業」に選ばれる高い技術力を持ち、世界初の医薬品を数々開発しています
  • 希少疾患のための薬を手がけています
  • 働き方の整備に積極的です

[Responsibilities]
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.

※詳しい業務内容はお問い合わせください。

[Requirements]

  • 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

[Employment Type]
Full time

[Salary]
10M-18M yen
※Experiences and skills will be considered

[Location]
Tokyo

[Interview Process]
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.