Manager, Clinical Science

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Job Description

OBJECTIVES/PURPOSE

• This position is responsible for the scientific direction for the assigned clinical development programs
• This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create maintain and execute a clinical development plan and study design that will result in the regulatory interaction consultation filing and approval of the compound in the therapeutic area
• This individual interacts with internal (e.g. GPT/CST JPBU Research PS GMS and other functions at TDC-J/R&D Japan) and external (e.g. KOL regulatory authority and patient advocacy group) stakeholders and influences JPL decision-making by setting strategic and scientific direction and providing expert therapeutic area and clinical development input

ACCOUNTABILITIES

Lead the clinical development from a viewpoint of science

• Create the CDP and LCM plan lead discussion at JDT and align with CST (and GPT if applicable)
• Create the study synopsis lead discussion at JDT and align with CST (and GPT if applicable)
• Review the ongoing study data and evaluate the clinical study results scientifically
• Create the regulatory consultation and filling strategies and proceed with scientific discussion with the regulatory authority
• Create the overall strategy of the CTD and be responsible for the registration document
• Engage with external stakeholders (e.g. KOL regulatory authority and patient advocacy group) for accelerating the clinical program
• Investigate medical practice and environment and incorporate them into the CDP and study design
• Lead scientific evaluation for in-licensing and out-licensing candidate compounds
• Support publication activities with JMO
• Support project activities for internal stakeholders (e.g. GPT/CST JPBU Research PS GMS and other functions at TDC-J/R&D Japan) from a viewpoint of science
• Explore new project proposals for contributing to the TAU strategy
• Provide team members with advice and opportunities to develop their abilities for the project

CORE ELEMENTS RELATED TO THIS ROLE

• Exploit the clinical science expertise/knowledge/experience integrate inputs from KOLs and be responsible for the CDP and study design
• Proceed with and support the clinical development from a viewpoint of science engage with JDT and enhance an alignment with CST (and GPT if applicable)
• Provide team members with advice and opportunities to develop their abilities for the project

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Have a deep knowledge and understanding about the latest science
• Have a broad knowledge and understanding about statistics regulation pharmacokinetics and preclinical etc. for creating the CDP and study design
• Have a deep communication skill (e.g. English) to effectively collaborate with CST (and GPT if applicable)
• Have a deep knowledge and expertise about diseases in the therapeutic area in charge
• Preferable to have a leading experience or recognized equivalent skills and knowledge for the clinical development;
  • Initiation activities for early-stage clinical development and planning/execution activities for late-stage clinical development (e.g. a pivotal study)
  • Activities for the filing and approval
• Preferable to have an experience related to leading and creating the clinical development strategy
• Preferable to have an experience related to collaboratively working with internal stakeholders outside TDC-J/R&D Japan (e.g. GPT/CST JPBU Research PS and GMS)

Leadership

• Engage other internal subject matter experts (e.g. statistics regulatory pharmacokinetics medical writing and preclinical) integrate the opinions and idea and decide the CDP and study design
• Preferable to have an experience related to the clinical development in the global matrix organization
• Collaborate with team members for improving their capabilities competencies and skills and provide an opportunity for their growth with appropriate feedbacks

Interaction

• Effectively communicate with CST (and GPT if applicable) and external stakeholders (e.g. KOL regulatory authority and patient advocacy group)
• Clearly explain the therapeutic area and disease related topics with deep understanding build appropriate relationship and interaction and communicate for accelerating the clinical development
• Clearly communicate with English addition to describing own opinions preferable to facilitate and lead the team discussion resulting in reaching the consensus
• Have a deep discussion with others in complicated communication situation
• Have a clear and brief presentation with interactive communications
• Have an ability knowledge and understanding about diversity/inclusion/equity in order to effectively discuss with the internal and external stakeholders
• Clearly explain a vision strategy and information of TAU and also medical and scientific values of compounds and unmet medical needs in medical practice and environment

Innovation

• Consider all of opportunities as comprehensively taking into account scientific information medical practice opinions from KOLs and regulatory authority and regulation for creating the appropriate CDP and study design
• Have a responsibility on explaining the project with scientific justification to JDT and CST (and GPT if applicable) and lead the team commitment
• Consider the improvement of the work process on the CDP/study design and project management and propose idea and approach for creating new changes with options to leverage external skills and knowledge
• Propose new or improved idea for new or current disease area as meeting the latest TAU strategy
• Propose new or improved activities for impacting the company activities regardless of project or non-project

Complexity

• Integrate complicated information from science medical practice opinions from KOLs and regulatory authority and regulation for creating the appropriate CDP and study design
• Recognize the latest work process and environment as discussing new idea and innovative approach and consider the process improvement and value maximization
• Make an adjustment for the project goal and activities in accordance with medical practice and environment to be expected in the future

Decision-making and Autonomy

• Reach an agreement and consensus on the CDP and study design at JDT and with CST (and GPT if applicable) based on the latest scientific information and medical practice/environment
• Have a responsibility on explaining the development strategy and execution of the project
• Preferable to discuss organizational issues and determine new challenges in non-project activities

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS

• Have a master or doctor degree or recognized equivalent skills and knowledge for life science (e.g. medical pharmaceutical science agriculture and physical science)

Takeda Compensation and Benefits Summary:

• Allowances: Commutation Housing Overtime Work etc.

• Salary Increase: Annually Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30 Production Sites (Osaka/ Yamaguchi) 8:00-16:45 (Narita) 8:30-17:15 Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays Sundays National Holidays May Day Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave Special Paid Leave Sick Leave Family Support Leave Maternity Leave Childcare Leave Family Nursing Leave.

• Flexible Work Styles: Flextime Telework

• Benefits: Social Insurance Retirement and Corporate Pension Employee Stock Ownership Program etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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