Astellas Pharma Inc. Recruit

Early Development / Clinical Operations are the departments in charge of generating clinical data, mainly in patients, during pharmaceutical research and development activities. These departments are responsible for planning and conducting clinical studies (clinical trials) intended to evaluate and confirm the efficacy and safety of investigational products in patients.

Overview

A new pharmaceutical product candidate selected based on the results of non-clinical studies is first investigated in a small number of healthy volunteers in Phase I clinical studies to evaluate the safety and pharmacokinetics in humans. If safety in humans is confirmed and the clinical dose is estimated based on pharmacokinetic data from Phase I studies, clinical studies in actual patients can be conducted.
Usually, safety and efficacy are evaluated and the optimal dosage and administration are investigated in the Phase II studies in patients. The results obtained in the Phase II studies are confirmed through comparisons with a control drug (an existing drug for the same indication or a placebo) in the Phase III studies.
In addition to conducting appropriate clinical studies in compliance with GCP* guidelines, Early Development / Clinical Operations are in charge of key tasks, such as evaluating the efficacy and safety data of new pharmaceutical products and their risks and benefits, which are the core data for applications for drug approval to be submitted to the Ministry of Health, Labour and Welfare (MHLW). Moreover, clinical studies are supported by patients providing voluntary consent for participation and cannot be conducted without the understanding and cooperation of physicians, nurses, pharmacists, laboratory technicians, and clinical research coordinators (CRCs) at medical institutions. For this reason, the team in charge of clinical development is always required to act responsibly to gain the trust of the parties involved in clinical studies.
Recently, we have also been conducting multi-national clinical trials that make it possible to apply for approval globally at almost the same time and, thus, we share information with overseas research and development divisions, collaborate with each of these divisions to ensure efficient research and development, and aim to deliver innovative new pharmaceutical products to patients around the world as early as possible.

*GCP (Good Clinical Practice)
The MHLW Ordinance on Good Clinical Practice. In conducting clinical studies (clinical trials), protecting study participants (human rights and safety) and ensuring the reliability of clinical study data (quality and results) are essential, and this is why "Good Clinical Practice (GCP)" was established

Structure of the departments

The division is divided into two departments according to therapeutic area to enhance global collaboration, flexibility and efficiency of resource management within clinical development functions, as well as to develop new pharmaceutical products in various therapeutic areas by increasing expertise.
Moreover, we have recently been involved in the development of Astellas’ Rx+ project, contributing to the creation of new healthcare solutions that go beyond pharmaceutical product development.

Early Development

From Phase 1 studies to eary Phase 2 studies (initial evaluation on whether investigational product shows expected safety and efficacy), and clinical pharmacology studies including Phase 1 healthy volunteer studies, drug-drug interaction study, clinical studies in patients with renal or hepatic impairment, etc.

Clinical Operations

Late Phase 2 studies and Phase 3 studies, and also all clinical studies in Rx+^® projects

A few words from the Department Head

The mission of pharmaceutical companies is to provide better pharmaceutical products to patients who are fighting diseases. Early Development and Clinical Operations are the departments in charge of the planning, design, and conduct of clinical studies at the final stage of new pharmaceutical product development, and this is where we realize that investigational products can help patients worldwide treat their diseases.
On the other hand, it is necessary to advance the clinical studies while sufficiently paying attention to safety and quality. Thus, each member is required to act based on high ethical standards and scientific grounds. It comes with heavy responsibilities, but is also a very rewarding job.
"Deliver much-needed medications to patients as early as possible"
"For the patients and for us"
These are the slogans we live by, and the principles that guide our daily challenges.
Our departments are global organization, so we are executing global clinical studies in collaboration with the US and Asian colleagues. There are many opportunities to work with global roles and responsibilities. If you wish to contribute to the health of people around the world, are full of passion, want to be able to work actively in a global setting, and have a strong spirit for taking on challenges, we hope you will join us. We look forward to receiving your application.

The Development Project Management is a division that globally manages clinical development projects for new drug candidates from the company's own research institute, or partner companies or research institutions, to get approval in countries all over the world with the optimized clinical development strategy and plan. We contribute to making clinical development strategies and plans for development projects, and manage schedules, budgets, and risks through close communication and collaboration with key stakeholders in Japan, Asia, the United States, and Europe. We advance the development of new pharmaceutical products in an optimal way by timely capturing and reflecting changes in the environment surrounding individual development projects, as well as associated risks.

Overview

In order to deliver possible new pharmaceutical product candidate compounds and modalities to patients around the world as quickly as possible, we support the advancement of development projects as project managers in collaboration with various internal stakeholders including the Development Division, Research Division, Pharmaceutical Technology Division, Commercial & Marketing Division, Medical Affairs Division, Pharmaceutical Affairs Division, and Pharmacovigilance Division, as well as external stakeholders.
The project manager gets involved in and contributes to making the clinical development strategy and plan for the clinical development projects as a member of the Global Development Project Team. The team considers strategies and plans from various perspectives addressing what package of clinical studies will be conducted based on patient population, geography and timing. The strategy and plans proposed by the team are implemented by the team as a development plan after internal governance approval.
In order to implement the development plan, it is necessary to appropriately manage the progress and budget. In general, any development project has the risk of not moving forward as expected and planned. Therefore, risk management is an important element for the smooth advancement of a project.
The Development Project Management Department works and collaborates with members of various divisions in various regions to appropriately and promptly advance development projects based on optimal development plans that align with development strategies, thereby contributing to the timely delivery of necessary medical care to patients.

Divison features

The Development Project Management consists of the following two groups:

Project Management Group 1

This group is responsible for the project management of development projects in areas other than oncology, such as immunity, transplantation, gene & cell therapy, neuromuscular diseases, ophthalmology, and gynecology.

Project Management Group 2

This group is responsible for the project management of development projects in the oncology area (immuno-oncology development, oncology development).

A few words from the Division Head

Data Science is in charge of the series of activities from clinical development planning to the development of clinical study protocols, design the case report forms and develop the database, data collection, cleaning and reviewing collected data, data processing for data analysis, data analyses, evaluation, and preparation of reports. In addition, we work to standardize statistical analysis plans, analysis datasets, and case report forms globally to support and promote each activity in clinical studies, as well as methods of globally managing clinical data, etc., and plan, maintain, and manage the tools used.

Overview

The activities of each group within the division are as follows:

Data Management (DM)

This group is in charge of designing and developing database for case report forms and eCOA, cleaning, reviewing and central monitoring of collected data, user account management, planning, maintenance, and management of clinical data management tools, global standardization of clinical study data (CDISC support), and quality control to ensure the quality and reliability of clinical data. These are highly important tasks in the quality control of clinical data globally as the data is one of the major assets of a pharmaceutical company.

Statistical and RWD Science (SRS)

This group is responsible for the statistical issues associated with the design, conduct, analysis, evaluation, and reporting of clinical studies. In particular, making full use of statistical knowledge to scientifically develop study protocols, such as a review of designs and sample size calculations, is important to enable the rapid and efficient development of new pharmaceutical products and to collect data that enable clear decision making. It is also necessary to leverage real world data and to create valuable information via epidemiological viewpoint. In addition, when carrying out projects in collaboration with Europe, the United States, and Asia, highly specialized activities also include discussing the statistical analysis and exchange of data in consideration of cutting-edge knowledge and regulations.

Medical Writing (MW)

This group is responsible for document production required for the development of pharmaceutical products and medical devices and for regulatory submissions. Specifically, we mainly prepare documents related to clinical studies, such as documents intended for submission to start clinical studies, clinical study protocols, Investigator's Brochures and clinical study reports, and documents for new drug application. We also prepare documents for post-marketing survey study and for clinical study information disclosure. These are highly specialized tasks to prepare accurate and scientifically valid documents to appropriately include necessary information in accordance with the type and purpose of the documents.

Data Sciences Business Operations Management (BOM)

This group supports coordination with external service providers to facilitate DM, statistical analysis, and MW activities. In addition, we support the adjustment of budgets, resources, establishment of workplace environments and infrastructure, etc. in order to smoothly promote various operations in the division. These are highly important activities that promote accurate, agile, and efficient execution of operations related to data sciences.

Clinical Data & Information Strategy (CDIS)

CDIS created in April 2023 to combine all experts in Data Science who are SMEs for data management and analytics solutions with the vision to drive optimal use of systems and data flow, drive innovation, further automation, adoption of AI solutions.

Department features

There are five groups in Data Science: DM, SRS, MW, BOM and CDIS. These groups are in charge of an important part of the operations in clinical studies; to plan, conduct, evaluate, and report.
In addition to responsibilities in clinical studies, DM and SRS are in charge of standardizing various documents, process, clinical data and analysis data globally. MW uses a globally document management system to create and manage documents using a global standard format and writing guides created for each document type. Data Science is woking globally in collaboration between regions.

Message from the Division

ED Clinical Pharmacology develops and implements early clinical development strategies and clinical pharmacology study plans, develops translational research plan, plan the strategic use of biomarkers, develop companion diagnostics and conducts Modeling & Simulation of study data (Model Informed Drug Development), to optimize the dosage and administration of pharmaceutical product candidates and make early informed decision for projects.

Overview

Early Development (Clinical Pharmacology Function)
ED Clinical Pharmacology develops and implements early clinical development strategies and clinical pharmacology study plans, develops translational research plan, plan the strategic use of biomarkers, develop companion diagnostics and conducts Modeling & Simulation of study data (Model Informed Drug Development), to optimize the dosage and administration of pharmaceutical product candidates and make early informed decision for projects.
ED Clinical Pharmacology is composed of the following groups

Oncology Clinical Pharmacology: Develop a clinical pharmacology strategy for oncology project.

Biopharma Clinical Pharmacology / Cell Gene Therapy: Develop a clinical pharmacology strategy for non-oncology project and cell/gene therapy project.

Translational Medicine: Develop plan and conduct translational medicine in collaboration with non-clinical research group and utilize the strategic application of biomarker research.

Precision Medicine: Develop plan for companion diagnostics for personalized medicine.

New Technology: Conduct mechanistic modeling (QSP, PBPK) and implement new computational technology (AI, ML) for MIDD.

Pharmacometrics: Conduct and plan Population PKPD analysis for dose optimization and develop MIDD.

Department features

Early Development Clinical Pharmacolgy is a global organization mainly in the US and Japan that contributed to drug research and development under the leadership of the global ED head. Various clinical pharmacology studies are conducted in the most appropriate region. On the other hand, the output from clinical pharmacology should be consistent and standardized across regions. For this reason, the members of ED Clinical Pharmacology are always working globally beyond regions.

Message from the Division