drjobs 【Janssen】 Japan R&D CS, Head of Neuroscience TA Clinical Development Department

【Janssen】 Japan R&D CS, Head of Neuroscience TA Clinical Development Department

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1 Vacancy
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Job Location drjobs

Tokyo - Japan

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

REQUIREMENTS:
Experience/Knowledge

5 years of pharmaceuticalindustry experience overall including clinical

developmentexperience at least three years. Preferable to demonstrate

leadershipin at least one development program which led to successful clinical

trialexecution and registration in Japan.

Skills/Capabilities

Demonstrates ability of strategicthinking and contingency planning with respect to pharmaceutical objectives.

Strong oral and writtencommunication skills in both English and Japanese.

Good planning and trackingskills.

Demonstrates influencenegotiation and conflict resolution skills including the ability to influencewithout clear reporting authority.

Good problem solving skills fordeveloping creative solutions.

Qualification/Certificate

M.D. Ph.D. or equivalent isrequired.

CRITICAL LEADERSHIP IMPERATIVES:

Builds strong and positiverelationships with MC members senior R&D leaders and partners colleagues andrelated functions.

Identifies unsolved needs perinsights and find effective solutions thought-out company-wide collaborations.

Delivers add-value solutions frominsights and challenge against status-quo for positive change onto the organization.

Takes risk and manage it withoutjeopardizing quality and/or compliance.

Responses talent developmenttalent fulfillment and performance improvement by having diverse visionsexperiences and ability.

Contributes high performanceorganization by transparent conversation.

Empowers to directreports/organizations to allow staff to act speedy agility and accountability.

Acts to help his/herorganizations to make global-wiidedecision-making which makes balance between short-term performance andlong-term vision.


JanssenJapan R&D CS Head of Neuroscience TA Clinical Development Department (Director)
JOB SUMMARY:
A member of the Japan R&D Leadership Team Head of TA-Dev is responsible for all scientific discussion/deliverables regarding all clinical development pipelines in assigned TA from early to post-marketing that JCoT (Japan Compound Team) is responsible. By co-working with Associate Director Head of TA-Dev is responsible to develop Integrated Evidence Generation Plan (IEGP) in partnership with core JCoT functions such as NPP BU and MAF that to be approved at strategy MC. The Head of TA-Dev is also responsible to develop and execute Japan Development Plan (JDP) that to be approved at JSRB as well as named Responsible Medical Officer (RMO) or its local delegate when Janssen Japan-sponsored clinical trial is executed in Japan.
KEY RESPONSIBILITIES:
Compound life cycle management:
Leads JCoT by co-working with Associate Director to develop IEGP that to be approved at annual ISD process and/or relevant MC meeting such as strategy MC.
Leads R&D KOL management.
Development planning and execution:
By co-working with Associate Director develops JDP that to be approved at JSRB and executes all approved studies and/or any activities.
Provides leadership as RMO or its local delegate to execute clinical studies in Japan whatever local or global from study start to study completion and study report creation including original article/presentation publication.
Provides leadership to file CTD as JNDA including labeling discussion.
Approves the members of study implementation structure of Janssen Japan each of clinical studies which are conducted in Japan.
Executes own authority defined in the authorization matrix attached.
Post marketing activities:
Contributes to launch readiness development.
Supports to develop risk management plan including post marketing surveillance studies led by JSS. (Japan Safety)
Provides leadership to execute post marketing clinical study from early preparation to completion if post marketing clinical study in Japan is considered.
Reporting lines and talent pipelines:
Responsible to assign Associate Director(s) to be reported to Head of TA-Dev.
Responsible for assessing potential in-house scientist/physicians identifying gaps in the talent pipeline and providing opportunity to region/global.



Required Experience:

Director

Employment Type

Full Time

Company Industry

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