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Associate Director or Manager, Quantitative Clinical Pharmacology, Data Sciences Institute/ クオンティテイティブクリニカルファーマコロジー, データサイエンスインスティテュート 主席部員または課長代理

Multiple Locations
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.

We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.

We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!

Job ID R0094980 Date posted 04/26/2023 Location Multiple Locations

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Job Description




Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

Takeda is the number one pharmaceutical company in Japan and a global industry leader –we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.


Quantitative Clinical Pharmacology:

Our Vision

To be a center of excellence in clinical pharmacology and enable model-informed global development of medicines, by finding the right dose for the right patients, with a purpose of maximizing benefit versus risk.

Our Mission

To enable rational dose selection through quantitative integration of pharmacokinetics, pharmacodynamics, safety, efficacy and sources of variability across patient populations, throughout the development lifecycle of our medicines.


・グローバルQCP leadと緊密に連携し、日本のCPに関連する開発ニーズをグローバル開発プログラムに組み入れること。
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

Liaise with scientific, industry and regulatory sectors for CP related matters.

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.

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

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


Seek opportunities to engage professional societies and external CP and drug development bodies to guide and influence the messaging on CP in drug development.

・治験責任医師と議論する等の機会においてスタッフのコーチング及びメンタリングを行い、会社主催のサイエンスアドバイザリーボードにSubject Matter Expectとして、研究者及びKOLとのディスカッションに参加するメンバーをサポートする。

Coach and mentor staff such that they are given opportunities to interface with the global investigator community through their presentations in such settings and support our department members when they serve as Subject Matter Experts at: company sponsored Scientific Ad Boards, interfacing with panels of leading academic investigators and KOLs.

Through meetings and publications develop as the external face of Takeda Quantitative Clinical Pharmacology.

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.

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. Will mentor and support his/her staff as they engage with regulatory authorities globally and may accompany members of clin pharm at Health Authority meetings in support of the need for decisions and agreements on scientific CP matters in such meetings. 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. Reviews and approves responses to time-critical queries from health authorities and position statements on key clinical development aspects like rationale for the proposed dose.

Be a seasoned (internally and externally recognized) leader within Takeda as well as and a strong CP scientist. Highly effective communicator and strong advocate for the discipline and utility of CP in supporting drug development.


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.



•生命科学関連分野における博士号または修士号相当 (薬理学、薬物動態、ファーマコメトリクス関連が望ましい)

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






•A minimum of 5 years Clinical pharmacologist experience.

•Extensive and broad experience with all phases of development in multiple therapeutic areas

•NDA and regulatory Inspection Experience

•Ability to handle multiple development programs simultaneously.



PMx関連の知識 (特に母集団解析及びE-R解析)





•Strong knowledge of Clinical pharmacology field

・Good knowledge on Pharmacometrics (especially on popPK and E-R)

・Experience of PK related software (Winnonlin, NONMEM, Simsyp, R, SAS etc)

•Solid understanding of clinical trial documents (synopsis, protocols, study reports etc) Briefing document, CTD and their processes.

•Advanced knowledge of PMDA and ICH regulations and industry standards and quality control principles.

•Good communications skills in both Japanese and English (at least business level), Logical thinking/Writing/Facilitation skills


















賞与: 原則年2回






Better Health, Brighter Future


Osaka, Japan

Tokyo, Japan

Worker Type


Worker Sub-Type


Time Type

Full time
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Where you fit in

When you join our Data Sciences Institute team, you’ll connect with a diverse and talented group of scientists, engineers and analysts. Together, you’ll define cutting-edge algorithms, conduct pharmacology-based modeling and explore new approaches to data services. In a collaborative environment marked by strong, open and honest leadership, you’ll take charge of your professional advancement as you work on important projects that grow your skills and lead to ongoing opportunities.

A career within the Data Sciences Institute at Takeda will give you everything you need to succeed professionally. You’ll see up close that what you do with information and insight has the power to impact the lives of patients — today and for generations to come. Working here, you’ll understand that our people-first perspective extends beyond patients to include our Takeda team, our families and the communities where we all work and live.

  • Work with various data sources

  • Apply a breadth of methodologies

  • Develop analysis pipelines

  • Design studies

The energy, professionalism and commitment that I experienced in every encounter, starting from the interview process, to meeting with the hiring manager, through to receiving an offer, left me feeling a certain level of consistency and thoughtfulness. That made me really feel enthusiastic.
headshot of brian johnson

Brian Johnson - Head, R&D Technology, Data Sciences Institute

Being able to predictably deliver on our portfolio priorities is where we have laser-focus each and every day. By doing this, we keep our eye on the prize of bringing new medicines to patients, and show the value that these treatments can bring to their lives.
headshot of simon davies

Simon Davies - Head, Statistical & Quantitative Sciences, Data Sciences Institute

We’re using the newest technology and methods, like wearable devices and machine learning, to better understand the health of patients participating in our trials.
headshot of ariel dowing

Ariel Dowling - Head, Sensing & Measurement, Digital Health Sciences

How you'll shine

Many talents one goal

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.


Create an exceptional people experience.


Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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