Associate Director, Quantitative Clinical Pharmacology, Data and Quantitative Sciences

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Job Description

Please note this job requires business level Japanese in speaking, writing, and reading.  

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

OBJECTIVES/PURPOSE

• Closely collaborates with Global QCP leads to ensure Japan regional clinical pharmacology development needs are integrated into the global clinical development plan.

• Provides appropriate guidance to the local Japan team members to ensure appropriate CP support to global and local development projects.

• Assists the global head of QCP by contributing to the technical and operational aspects of the CP within the company and by leading local CP initiatives as required, to ensure CP’s continued value and reputation within and outside the company.

• Leverage his/her broad development expertise across all stages of drug development and TAUs and MPD, to be a collaborative and informed expert in their field within the company to serve on cross functional and divisional initiatives in support of company objectives as required.

ACCOUNTABILITIES

• Demonstrate an excellent knowledge of CP relevant Japan regulatory guidelines. Ensures that such expertise is homed within the CP regions and as such ensures CP expertise is available to provide clin pharm scientific and strategic leadership in reviews of such documents when requested. Expected to review and approve key submission documents (i.e. summaries of biopharma and clin pharm within the CTD and CTNs) when generated from their region. Review and approve responses to time-critical queries from health authorities and position statements on key clinical development aspects like rationale for the proposed dose.

• Leverage his/her broad development expertise across all stages of drug development and TAUs and MPD, to be a collaborative and informed expert in their field within the company. And considered within Takeda R&D a subject matter expert/ technical advisor in the area of CP while keeping abreast of emerging scientific/ regulatory advances and contribute to development of internal best practices.

• Be engaged with project members/junior staff to make major assessments that drive decisions around asset value, risks and probability of technical and regulatory success to inform business decisions around strategic investments.

• Provide appropriate guidance to ensure appropriate CP support and input is provided to global and local development projects that are supported by the department and ensures CP resources at outsourced vendors assigned to support local/global development programs if needed.

• Assists the global head of QCP by contributing to the technical and operational aspects of the CP within the company and by leading local CP initiatives as required, to ensure CP’s continued value and reputation within and outside the company.

• Seek opportunities to engage professional societies and external clin pharm and drug development bodies to guide and influence the messaging on CP in drug development. And through meetings and publications develop as the external face of Takeda Quantitative Clinical Pharmacology.

• Supported to allow their maximum contribution to development teams through the application of their drug development expertise and quantitative PK/PD approaches.

• For projects that may occasionally be asked to support: ensure high quality relevant documentation are prepared.

CORE ELEMENTS RELATED TO THIS ROLE

• Formulate and execute strategies for efficient operation of clinical pharmacology mainly from a cross-project perspective in collaboration with relevant divisions in and outside Japan and the project team.

• Collaborate with Global Function to support efficient collaboration among the Project Team, partner CRO and Global Members.

• As an expert, contribute to problem solving that occurs in the Project Team from a cross-project perspective in terms of QCP work.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Experience in clinical development of pharmaceuticals

• Broad knowledge and experiences of Clinical Pharmacology including Pharmacokinetic Analysis, Population PK analysis and modeling and simulation.

• Knowledge of pharmaceutical regulations in and outside Japan (ICH, Pharmaceutical Affairs Law, GCP, Notification of Clinical Trial Notification, etc.)

• Ability to solve problems through different approaches from various perspectives

• Project management techniques and business knowledge, methods for improving business processes, and creation of ideas

Leadership

• Coordinate with the project team, partner CRO, and Global Function from a cross-project perspective, lead problem solving in CP functional area, and build an efficient work operation system as an organization

• Based on past experiences and knowledge, cooperate with relevant divisions to build process and risk management in response to the changes in Takeda R&D and TDC-J’s business model going forward.

Interaction

• Build good relationships with the project team and internal and external stakeholders, and contribute to problem solving in the project team from a cross-project perspective

• Explain in a careful manner the most appropriate solution based on the standpoints of relevant parties including the global counterpart, along with its rationale, and negotiate the review of the current process, etc. as needed.

Innovation

• Create and maintain functional mid-long strategy with incorporating cutting edge technology/approach in clinical pharmacology under the supervision of the director.

• Identify the root cause of the problem and propose an optimal solution from several options that takes into account the environment surrounding the current organization.

• Make flexible proposals for solutions based on regulatory requirements, SOPs, etc.

Complexity

• While the environment surrounding the organization is changing, lead to find the optimal solution using a different approach with balancing multiple stakeholders inside and outside the company is required

• Draw up flexible and innovative solutions by referring not only to Takeda's traditional approach, but also to examples from other companies and other industries.

Decision-making and Autonomy

• Prioritize divisional issues based on organizational/divisional policies and draw up measures for each.

• Entrusted with the method to achieve measures (Tactics) and can act freely with the cooperation of relevant divisions inside and outside the company.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• PhD, MS or equivalent required in a health-related, life science area, preferably in Pharmacology, Pharmacokinetics or Pharmacometrics associated.

• Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD

• MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD

• Extensive and broad experience with all phases of development especially in Japan development and multiple therapeutic areas, and an ability to handle multiple development programs simultaneously.

• Experience of working with Japanese agencies, PMDA/MHLW, and hopefully other international regulatory agencies, such as MHRA, FDA, and EMEA.

• Good knowledge on Pharmacometrics, especially on population PK and E-R analysis and experience of at least one PK related software (Winnonlin, NONMEM, SimCYP, R, SAS etc.)

• Solid understanding of clinical trial documents (synopsis, protocols, study reports etc), briefing document, CTD and their processes and excellent writing skill to demonstrate CP concepts clearly.

• Excellent communications skills, including logical thinking and facilitation skills, in Japanese and English demonstrated by the ability to explain complex CP concepts to influence senior leaders in the formulation of CP strategy and direction.

• Takeda Global Core Competencies Role 3 required, and strong competencies especially in Engage Others, Collaboration, Drive for Results, and Strategic Approach

WORK LOCATION:

Osaka HQ

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.

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