【Janssen】IDV Therapeutic Area Lead (TA Lead)/ 疾患領域リード_MD or PhD


Summary:

•Lead implementation of Japan disease area vision, execute early assessment, pipeline gap analysis including inputs from BD and prioritization assessment (within therapeutic area) of candidate compounds for Japan in therapeutic area in charge.

•Lead initiation of JCoT formation with creation of a high level development strategy of the new compound(s) prioritized for Japan, considering based on disease area strategy and landscape, key elements of J-IEGP, unmet medical needs, possible target product profile, possible regulatory path, and policy, regulations and guidelines, etc. to consider, competitive intelligence, loss of exclusivity, etc. in Japan

Primary responsibilities

•Execute the following actions in therapeutic area in charge:

•Create, revise, implement and maintain Japan disease area vison and strategy.

•Create JCoT formation proposal, disease area strategy and landscape, key elements of J-IEGP, a high level compound strategy of the new compound(s) prioritized for Japan.

•Execute early assessment, pipeline gap analysis including inputs from BD and prioritization assessment (within therapeutic area) of candidate compounds for Japan.

•Create a high level compound strategy for candidate compounds, clarification of unmet medical needs, possible target product profile, possible regulatory path, and policy, regulations and guidelines, etc. to consider, competitive intelligence, loss of exclusivity, etc. in Japan though proactive discussion with NPP and MAF.

•Lead in-depth discussion within J-TASTe with regard to Key Business Questions (KBS), results of early assessment and prioritization assessment, etc.

•Lead preparation of annual ISD recommendations and transition to JCoT core members through Win-Win collaboration with related internal stakeholders such as JCDTL, RA, PM in R&D, NPP, Commercial and MAF.

•Execute compound strategy oversight of the on-going R&D pipelines including life-cycle management candidates.

•Create, update, implementation and maintain R&D KOL planning for identification of medical gaps – data gap, clinical gap and knowledge gap, and clarification of unmet medical needs, and discussion of therapeutic area/disease area strategy and compound strategy.

•Create and update TA annual plan, TA project update report, TA newsletter, etc.

•Execute unified R&D portfolio assessment in therapeutic area in charge, using TA strategy framework implemented.

•Execute Japan environment scan – policies, regulations, disease awareness trend, etc.

•Seek alternative internal and external opportunities; e.g. early development integration, collaborative research, epidemiology, etc.

•Propose the team assignment request.

•Become the contact person with the corresponding responsible persons in global R&D like Disease Area Stronghold Leader, etc. in the same therapeutic area.

•Execute appropriate communications with related external stakeholders.

•Execute appropriate control of the essential documents.

[Key area in line management]

•Execute capability development plan of talents including on the job training.

•Execute appropriate resource management within the group.

•Execute budget in a structured way.

•Approve related documents and process based on the job authorization policy.



Qualifications
Qualification: •Ph.D. or equivalent (M.D. – preferable).

•Sufficient experience/expertise in clinical development.

•Excellent interpersonal communication skill in Japanese.

•Business level of English communication skill.

Key skills & knowledge, etc.

-Coaching, strategic thinking and presentation.

-Professional level of knowledge on compound, medical science and disease, study designing, clinical evaluation, data interpretation, regulations, etc.

Key competency

-Make decision timely and appropriately even under limited information.

-Demonstrate stable performance completely while dealing with multiple tasks in parallel within work defined in the job description.

-Demonstrate stable performance completely while dealing with multiple tasks having a high degree of difficulty.

-Generate uniform high-quality outputs/deliverables.

-Manage risks including potential proactively.



Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Clinical Research non-MD
Requisition ID
1805644505W
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