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**Job Function: **
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function: **
Pharmacokinetics & Pharmacometrics
Job Category:
Scientific/Technology
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
JOB SUMMARY:
- Conduct 1) to 4) below in the non-clinical area.
Ensure appropriate studies are conducted at appropriate times to support development in Japan.
Ensure study results and their interpretation meet Japanese requirements.
Ensure resolution to all project-related problems that might affect development in Japan.
Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines.
Focus on self-evaluation, self-management and self-development.
Educate and coach the group members and make proper assignments and fair performance appraisals.
Plan and execute strategy of the group
Shape regulatory acceptance aligned with international standards through external/industry activities.
**KEY RESPONSIBILITIES: **List major responsibilities and duties of the position.
- Conduct 1) to 9) below in the non-clinical area.
Research global (e.g. JJPRD) documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDA's.
Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice.
Prepare high-quality non-clinical documents for clinical studies and/or NDAs.
Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with global, JPKK and/or external experts.
Provide support for preparing high-quality documents for marketing.
Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed.
Provide relevant colleagues with suggestions from non-clinical perspectives.
Establish, maintain and improve relationship to relevant colleagues and external experts.
Support the group members, and check the documents and/or responses prepared by the group members in terms of science and quality
Make the group's objectives in line with R&D's goal and share them with the group members.
Assign the group members to projects and change the members if needed.
Give feedback and coaching to the group members and make fair performance appraisals.
**REQUIREMENTS: **
Experience/Knowledge
. Expert knowledge of the non-clinical area, advanced knowledge of non-clinical notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, advanced knowledge of other non-clinical areas, and intermediate knowledge of clinical areas.
. Experience in non-clinical areas for more than 12 years or equivalent to the experience.
. Experience with activities outside the company or department
Skills/Capabilities
. Advanced presentation and negotiation skills with global mindset.
. Advanced communication skills in English.
. Advanced skills in managing and developing the group members, including
coaching, feedback and mentoring.
Qualification/Certificate
Ph. D or Equivalent
＜For Internal Applicants＞
Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.
**Required Skills: **
Preferred Skills:
Clinical Pharmacology, Clinical Trials Operations, Consulting, Drug Discovery Development, Industry Analysis, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research, Tactical Planning, Technical Credibility