【Janssen】 Japan R&D CS, Head of Neuroscience TA Clinical Development Department (Director)
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.
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.
・ 5 years of pharmaceutical
industry experience overall including clinical
experience at least three years. Preferable to demonstrate
in at least one development program which led to successful clinical
execution and registration in Japan.
・ 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
・ Demonstrates influence,
negotiation and conflict resolution skills, including the ability to influence
without clear reporting authority.
・ Good problem solving skills for
developing creative solutions.
・ M.D., Ph.D., or equivalent is
CRITICAL LEADERSHIP IMPERATIVES:
・ Builds strong and positive
relationships with MC members, senior R&D leaders and partners, colleagues and
・ 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 global-wi
decision-making, which makes balance between short-term performance and
Janssen Pharmaceutical K.K. (7195)
Clinical Research MD