Clinical scientists play a pivotal role in the drug development process, from planning development strategies and conducting clinical trials to analyzing results and liaising with regulatory authorities. Matsumoto and Kinoshita, both leaders in this field, along with Hiraoka, who leverages her clinical scientist experience as a clinical function leader, discuss the appeal of working at Chugai Pharmaceutical and the excitement of participating in clinical development.

*Reprinted from Chugai's official talentbook (https://www.talent-book.jp/chugai-pharm). The descriptions and affiliations are current as of August 2023.

Leading Clinical Development from a Scientific Perspective in Oncology and Specialty Areas

At Chugai Pharmaceutical, rapidly identifying the clinical value of innovative drug candidates is a top priority. In clinical development, clinical scientists take the lead from a scientific perspective, determining development policies, planning clinical trials, and managing regulatory interactions.

Kinoshita　"When transitioning from non-clinical/early development to late clinical phases, we formulate clinical development plans, considering aspects such as trial design, trial progression, and data collection and analysis. We also analyze trial results, prepare reports, and submit them to regulatory authorities, such as the Pharmaceuticals and Medical Devices Agency, to obtain approval.

Additionally, it is crucial to focus on maximizing product value; ultimately, how we can benefit patients. We proceed by determining what data would enhance the product and how best to express the anticipated effects of new drugs."

Matsumoto　"In developing new drugs, we assess the potential of candidates from non-clinical studies and formulate clinical plans to evaluate clinical efficacy and safety.

While clinical trial operations teams primarily handle trial management, clinical scientists play a key role in analyzing collected data and communicating with regulatory authorities."

Hiraoka serves as Senior Manager in the Oncology Clinical Development Department. She is currently responsible for both clinical function leadership and disease area leadership roles.

Hiraoka　"As a clinical function leader for Roche's anticancer drugs, I coordinate both science and operations, while simultaneously serving as a disease area leader (clinical) for gastrointestinal cancer.

Since joining the company, I've consistently worked in oncology. After gaining experience as a clinical development monitor, I moved into clinical science and now oversee the entire clinical development process, integrating both operational and scientific perspectives."

Matsumoto works in the same Oncology Clinical Development Department as Hiraoka, while Kinoshita is in the Specialty Clinical Development Department. Both serve as clinical science leaders, guiding clinical development from a scientific standpoint.

Matsumoto　"I am involved as a clinical scientist in multiple concurrent clinical trials targeting hepatocellular carcinoma. At Chugai Pharmaceutical, it is common for clinical scientists to manage multiple trials. I oversee trials at various stages—some already in progress, interacting with medical institutions, and others preparing for submission."

Kinoshita　"I oversee the ophthalmology area. I transitioned from a company that manufactures and sells ophthalmic drugs following the release of an ophthalmology product in 2022. Currently, as a critical science leader, I am responsible for conducting introduction evaluations, executing clinical trials from a scientific perspective, and handling approval applications."

Appeal of a Rich Pipeline: New Possibilities Created by Partnership with Roche

Chugai Pharmaceutical develops products both in-house and through licensing agreements with Roche and its subsidiary, Genentech. All three interviewees agree that the appeal of working in clinical science at the company lies in its rich development pipeline.

Kinoshita　"I find the development pipeline abundant and innovative, particularly in addressing intractable diseases. It is rare to work with a pipeline that has the potential to significantly benefit patients, and I take pride in leading initiatives with such a high social impact."

Matsumoto　"Chugai offers numerous opportunities to collaborate with Roche and Genentech, providing a unique vantage point on clinical science from a global perspective.

Additionally, we have products developed in-house, utilizing our own scientific and technological capabilities. The company actively discusses the direction of both domestic and international development, offering employees the chance to engage with clinical science on a global scale.

During a Phase I clinical trial at Genentech, which involved the first administration of a drug to humans, I was impressed by their bold trial design. They ensured patient safety while pushing the boundaries of conventional guidelines. For someone like me, who had always believed in strictly following guidelines, this experience was eye-opening. It taught me the importance of innovation while still adhering to regulatory standards, and I aim to apply these lessons in future trial designs."

Hiraoka　"I share your views and believe that Chugai Pharmaceutical’s strength lies in the richness of its development pipeline. While the clinical development department primarily manages late-phase trials, such as Phase II and Phase III, we also handle many in-house development products in Phase I or pre-Phase I stages, with the expectation of advancing to later phases.

While late-phase development is often transferred to Roche, Chugai increasingly contributes by providing input and co-developing plans. Collaborating with Roche’s world-class scientists offers valuable learning opportunities, not only in scientific expertise but also in global leadership and personal development.

In recent years, there has been a concerted effort to formulate development plans and collect data in collaboration with other functions, such as medical and non-clinical teams, while also incorporating the perspectives of doctors and patients. I believe that this integrated approach is another key appeal of working at Chugai."

Meanwhile, Chugai Pharmaceutical is also focusing on developing digital and wearable devices to quickly detect safety issues in patients' treatment and enhance therapy. The opportunity to engage in such innovative initiatives is a significant advantage for those involved in clinical science at the company.

Matsumoto　"At Chugai Pharmaceutical, there is a culture of actively incorporating new technologies into clinical trials. Rather than simply following industry trends or proceeding with conventional trial methodologies, the company promotes continuous innovation and improvement."

Kinoshita　"As Roche also conducts clinical science, we must clearly define the role of Chugai Pharmaceutical’s clinical science. To establish our presence, it is essential to continually embrace new challenges. Perhaps the greatest appeal of our clinical science is our commitment to avoiding complacency and our willingness to embrace change."

Development, Career Support, Work-Life Balance: Highly Flexible Work Style Possible at Chugai

The three interviewees also find Chugai Pharmaceutical’s corporate culture appealing. Drawing from their respective positions and experiences, they describe the characteristics and strengths of colleagues at the company.

Hiraoka　“Roles and responsibilities are clearly defined for each position, but many employees go beyond their duties to develop additional skills for self-improvement.

The Clinical Development Division is a large organization, and I find that many colleagues value teamwork and have a strong sense of camaraderie."

Matsumoto　"I agree! Teamwork is highly valued. In clinical development, we regularly collaborate with multiple departments, and many people demonstrate strong communication skills and situational awareness. There is also a noticeable adventurous spirit among staff."

Kinoshita　"I believe there is a strong culture of mutual support. When I proposed creating a knowledge-sharing system for new members, a structure was quickly put in place to organize materials and host study sessions. I feel that people are open to expressing ideas and work together to improve the organization."

Hiraoka, the only one among the three to join Chugai as a new graduate, notes that the company provides a comprehensive development system, including on-the-job training (OJT) and career support programs.

Hiraoka　"In addition to standard training for new employees, the Clinical Development Department offers a unique program called CLOVER training, where new hires rotate through various departments involved in clinical development for about six months. Having senior employees as OJT coaches was also very helpful. For career support, we have quarterly consultations with supervisors.

My impression is that many supervisors actively listen and offer guidance on career development. In my case, I aimed to gain experience in both operations and clinical science to become a clinical function leader. I started as a clinical development monitor, then became a study leader in operations, and later moved into clinical science, gradually expanding my responsibilities with guidance from my supervisor."

Matsumoto, who joined Chugai mid-career from a background in non-clinical research, reflects on her smooth transition into clinical development despite limited prior experience.

Matsumoto　"I was assigned to a project immediately after joining and learned by working on practical tasks alongside my OJT coach. I felt that assignments were aligned with my experience and skill level. Being able to collaborate with experienced senior employees was extremely beneficial. Career support is also strong, likely due to the depth of the development pipeline. There is an environment that offers early opportunities, and although not all requests are granted, the company tends to accommodate employees’ preferences. For example, I was appointed as a clinical science leader, which was one of my personal goals."

Kinoshita, another mid-career hire, describes her first 18 months at Chugai as a time of proactive learning and personal growth.

Kinoshita　"Chugai supports employees who want to learn independently, such as by providing access to online learning platforms. One initiative that stood out was 'Chugai Academia,' where employees propose a topic they wish to study, and others from different departments join voluntarily to learn together.

In my first year, I studied Chugai’s business model with colleagues from the Sales Division and the Quality Assurance Department, which also helped build my internal network."

All three interviewees also serve as parents. They agree that Chugai provides a supportive environment for balancing childcare and work.

Hiraoka　"We have a flextime system without core hours, allowing work between 5 a.m. and 10 p.m. I have three children, and thanks to this system, I can work full-time without reducing my hours.

Even when I worked shorter hours, the company respected my preferences, such as taking on specific roles despite a reduced workload. I am grateful for Chugai’s willingness to accommodate employees’ needs."

Matsumoto　"The flextime system has been very helpful. I can take a break to pick up my child and prepare dinner, then resume work later. This flexibility eased my transition back after maternity and childcare leave."

Kinoshita　"The high degree of flexibility is very attractive. Now that the COVID-19 pandemic has subsided, the Clinical Development Department recommends coming to the office once a week. However, this is not enforced. In true Chugai fashion, we have implemented creative ideas to encourage

Clinical Development at Chugai Pharmaceutical Enters a New Phase with New Colleagues

Each of the three contributors to Chugai’s clinical development expresses a different vision for the future.

Hiraoka　"It has been a year and a half since I became a clinical function leader, and I am finally getting accustomed to the role. My immediate goal is to grow into the position. Chugai’s Clinical Development Department often handles development for Roche products. While we align with Roche’s plans, I believe the future challenge for oncology development is to proactively propose strategies for cancer types prevalent in Japan and Asia."

Matsumoto　"I aim to become a clinical function leader, like Hiraoka. In that role, I want to lead development efforts that deliver optimal treatments to patients while increasing collaboration with other departments.

I am also considering exploring areas beyond clinical development. Chugai’s in-house internship system allows employees to gain experience in other departments, and I hope to gain new insights through that opportunity."

Kinoshita　"My short-term goal is to perform well in my current role. Like Matsumoto, I aspire to become a clinical function leader and contribute at a higher level across entire projects.

One of our ophthalmology team members is currently assigned to Genentech, and I’m considering similar opportunities to collaborate with overseas teams. I hope to take on bold challenges and contribute more meaningfully to pharmaceutical development."

New colleagues are essential for the Clinical Development Department to advance development strategies and create protocols in collaboration with both domestic and international teams. Matsumoto and Hiraoka extend an invitation to prospective team members:

Matsumoto　"In many companies, clinical science and trial operations are separate departments. At Chugai, you can work across both areas within the same department. We would welcome individuals who want to expand their roles and responsibilities continuously."

Hiraoka　"Since May, I've been working on the same project as Matsumoto, and her background in non-clinical research brings valuable perspectives to the team. Clinical development experience is not a requirement. I look forward to working with motivated individuals."