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I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** + This position is responsible for the scientific and medical 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 strongly influences JPL decision-making by setting strategic, scientific, and medical direction and providing expert therapeutic area and clinical development input + This individual clearly explains the TAU strategy to subordinates and/or team members, and develop/lead their ability and competency + This individual establishes a new framework, structure, and procedure, etc. to contribute to the TAU strategy + This individual provides team members with medical input from medical knowledge, expertise, and experience **_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 and medical evaluation for in-licensing and out-licensing candidate compounds + Provides team members with medical input from medical knowledge, expertise, and experience + 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 + Explain clearly the TAU strategy to subordinates and/or team members, and develop/lead their ability and competency + Contribute tasks outside own projects + Establish a new framework, structure, and procedure, etc. to contribute to the TAU strategy **_CORE ELEMENTS RELATED TO THIS ROLE_** _(Describe what is critical and/or what differentiates 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 completely have an alignment with CST (and GPT if applicable), in accordance with medical practice and environment to be expected in the future + Explain clearly the TAU strategy to subordinates and/or team members, and develop/lead their ability and competency + Establish a new framework, structure, and procedure, etc. to contribute to the TAU strategy **_DIMENSIONS AND ASPECTS_** **Technical/Functional (Line) Expertise** + Have a deep knowledge and understanding about the latest science and medical practice + 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, in order to contribute to the TAU strategy + 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 >=5 years of experience related to the clinical development + 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** _(Vision, strategy and business alignment, people management, communication, influencing others, managing change)_ + 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 + Lead the global discussion and proceed with the clinical development in the global matrix organization (e.g., as a GCL) + Collaborate with subordinates and/or team members for improving their capabilities, competencies, and skills, and provide an opportunity for their growth with appropriate feedbacks **Interaction** _(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)_ + 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 speakers. In addition to describing own opinions, 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** _(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)_ + 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 and medical 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** _(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)_ + 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** _(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)_ + 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 + Identify and implement new challenges in non-project activities to solve organizational issues **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** + Have the competency level of >= Role 3 in all of the GCCs + Have a MD degree. PhD is preferable + >=900 of TOEIC score, or recognized equivalent English score **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 company’s discretion. + It is possible the department and workplace may change at the company’s discretion. **Locations** Osaka, Japan **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time