Manager, Non-clinical Pharmacology | Non-line manager | R&D Alliance, Kobe Pharma Research Institute

Basic Purpose of the job:

• Prepare and finalize non-clinical pharmacology documents for PMDA submission. Be representative for key interactions with PMDA in terms of non-clinical pharmacology, aiming for commercial success of Boehringer's products
• Make value propositions for all New Molecular Entities (NMEs) in the Japanese market from a biopharmaceutical perspective

Accountabilities - Related Performance Indicators:

Understand Global Master Dossier for each NME and prepare its Japanese version of non-clinical section to fit the local requirement, and to address unmet medical needs clearly

・Development of strategic plan for Japanese version preperation to differentiate the product (e.g. additional data, wordings, etc)
・Implementation documentation/review process with well alignment with overall J-NDA submission timeline
・Finalize non-clinical pharmacology section for each submission in timely manner 

Make value propositions for NME in the Japanese market from a biopharmaceutical perspective in collaboration with MAHA:

・Deep understanding of competitive landscape and SoC in the field
・Alignment with MAHA interms of pricing strategy
・Preparation of non-clincal paharmacology section of the pricing claims to clarify key differentiators of NME from competitors as well as from SoC in line with the pricing strategy

Act as the interface between Japan team and Global Discovery Research (non-clinical pharmacology group)

・Communicate with the non-clinical pharmacology group for each project to obtain sufficient infromation and data, which are not included in GMD, to strengthen value proposition
・Keep Japan team updated in terms of non-clinical feature of the project

Propose and plan non-clincal studies for NMEs that create meaningful differentiation from competitors and SoC

・Identify key differentiators of NME during early clinical phase
・Propose non-clinical studies if similar studies have not been conducted in house in timely manner
・Plan and lead the studies if applicable

Actively participate Development Japan

Interfaces:

Project management, Clinical operation, Non-clinical pharmacokinetics, Non-clinical toxicology, Non-clinical analytics

Required Education:

Doctoral Degree eg. PhD or MD　博士修了

Biology　生物学                    
Pharmacology

Required Capabilities (Skills, Experiences, Competencies):

Special Skills
• Proven track records in regulatory science activites in non-clinical pharmacology
• High communication skills in English / Japanese, especially in conflicted situation
• Strategic thinking
• Knowledge of regulatory related laws and guidelines in drug development

Language Skills & Proficiency:

Japanese: Native/Fluent    
English: Native/Fluent

Requires Experience:

International Experience:
Int'l exposure in daily business (>50%of international business / customers / staff) > 1.5 years ～ 4 years

Special Work Experience
• > 5 years experiences of working for  pharmaceutical R&D (ideally international pharma)
• Proven performance record of working in the field of responsibility (>10 drug development projects)
• Good connection with academia and authorities