Johnson & Johnson Careers

【Janssen】 R&D Japan, Clinical Development Project Leader (Associate Director)_Solid Tumors

Chiyoda, Japan
Clinical Research non-MD


Job Description

Requisition ID: 1805699049W

Janssen R&D Japan, Clinical Development Project Leader (Associate Director)_Solid Tumors

 
JOB SUMMARY:

Together with Head of TA-Dev, Assoc. Dir is responsible for all scientific discussion/deliverables regarding all clinical development activities in the assigned compound(s), from early to post-marketing, that JCoT (Japan Compound Team) is responsible. Assoc. Dir is responsible to develop Integrated Evidence Generation Plan (IEGP) together with JCoT core members such as NPP, BU, and MAF, that to be approved at strategy MC. Assoc. Dir is also responsible to develop and execute Japan Development Plan (JDP) that to be approved at JSRB, as well as oversee milestones of all clinical studies when Janssen Japan-sponsored clinical trial is executed in Japan.

 
KEY RESPONSIBILITIES:

Compound life cycle management:

・ Leads JCoT to develop IEGP that to be approved at annual ISD process and/or relevant MC meetings such as strategy MC.

・ Leads R&D KOL management.

Development planning and execution:

・Develops JDP that to be approved at JSRB and executes all approved studies and/or any activities.

・Create and update clinical study plan fulfilling clinical data package for J-NDA submission, considering the target product profile of the assigned compound.

・Provides leadership, as equivalent responsibility of Head of TA-Dev, 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.

・ Requests the members of Japan Clinical Team at appropriate timing.

・ 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.

・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 Japan Clinical Lead, Japan Clinical Scientist and Study Responsible Physician

(in case of independent clinical study in Japan – Local study) to be reported to Assoc. Dir.

・ Responsible for assessing potential in-house scientist/physicians, identifying gaps in the talent pipeline and providing opportunity to region/global.

 

Line Management:

Manage & Develop 1-3 subordinate as direct report line



Qualifications
REQUIREMENTS:
Experience/Knowledge

・5 years of pharmaceutical industry experience overall including clinical development experience at least 3 years.

・Preferable to demonstrate leadership in at least one development program which led to successful clinical trial execution and registration in Japan. (Or clinical development related project management experience)

Lung cancer or gastrointestinal cancer experience is highly regarded.

 
Skills/Capabilities

・Demonstrates ability of strategic thinking and contingency planning with respect

to pharmaceutical objectives.

・ Strong oral and written communication skills in both English and Japanese.

・ Good planning and tracking skills.

・ Demonstrates influence, negotiation and conflict resolution skills, including the

ability to influence without clear reporting authority.

・ Good problem solving skills for developing creative solutions.

CRITICAL LEADERSHIP IMPERATIVES:

・Builds strong and positive relationships with MC members, senior R&D leaders and partners, colleagues and related functions. ú

・Identifies unsolved needs per insights, and find effective solutions thought-out company-wide collaborations.

・Delivers add-value solutions from insights, and challenge against status-quo for positive change onto the organization.

・Takes risk and manage it without jeopardizing quality and/or compliance.

・Responses talent development, talent fulfillment, and performance improvement, by having diverse visions, experiences, and ability.

・Contributes high performance organization by transparent conversation.

・Empowers to direct reports/organizations to allow staff to act speedy, agility and accountability.

・Acts to help his/her organizations to make company-wide decision-making, which makes balance between short-term performance and long-term vision.



Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Clinical Research non-MD
Requisition ID
1805699049W