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Job Description

OBJECTIVES/PURPOSE

This position is responsible for the scientific and medical direction for the assigned clinical development programsThis 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 areaThis 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 inputThis individual clearly explains the TAU strategy to subordinates and/or team members, and develop/lead their ability and competencyThis individual establishes a new framework, structure, and procedure, etc. to contribute to the TAU strategyThis 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 scientificallyCreate the regulatory consultation and filling strategies, and proceed with scientific discussion with the regulatory authorityCreate the overall strategy of the CTD and be responsible for the registration documentEngage with external stakeholders (e.g., KOL, regulatory authority, and patient advocacy group) for accelerating the clinical programInvestigate medical practice and environment, and incorporate them into the CDP and study designLead scientific and medical evaluation for in-licensing and out-licensing candidate compoundsProvides team members with medical input from medical knowledge, expertise, and experienceSupport publication activities with JMOSupport 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 scienceExplore new project proposals for contributing to the TAU strategyExplain clearly the TAU strategy to subordinates and/or team members, and develop/lead their ability and competencyContribute tasks outside own projectsEstablish 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 designProceed 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 futureExplain clearly the TAU strategy to subordinates and/or team members, and develop/lead their ability and competencyEstablish 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 practiceHave a broad knowledge and understanding about statistics, regulation, pharmacokinetics, and preclinical, etc. for creating the CDP and study designHave 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 strategyHave 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 approvalPreferable to have >=5 years of experience related to the clinical developmentPreferable to have an experience related to leading and creating the clinical development strategyPreferable 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 designLead 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 developmentClearly communicate with English speakers. In addition to describing own opinions, facilitate and lead the team discussion resulting in reaching the consensusHave a deep discussion with others in complicated communication situationHave a clear and brief presentation with interactive communicationsHave an ability, knowledge, and understanding about diversity/inclusion/equity in order to effectively discuss with the internal and external stakeholdersClearly 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 designHave a responsibility on explaining the project with scientific and medical justification to JDT and CST (and GPT if applicable), and lead the team commitmentConsider 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 knowledgePropose new or improved idea for new or current disease area as meeting the latest TAU strategyPropose 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 designRecognize the latest work process and environment as discussing new idea and innovative approach, and consider the process improvement and value maximizationMake 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/environmentHave a responsibility on explaining the development strategy and execution of the projectIdentify 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 GCCsHave 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.

LocationsOsaka, Japan

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time