Japan Medicine Development Lead (J-MDL) Specialty

【Job Purpose】

The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to

ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL

serves as the asset level point-of-contact for Medicine Development Leader (=MDL), and asset single point

of contact to Japan senior management and Japan governance board. JMDL must work closely with MDL

not only successful launch for Japan but also overall success for GSK Global as one of the key leaders in

Global Medicine Development Team (=MDT).

【Key Responsibilities】

⚫ Provide leadership and collaborates with the central Medicine Development Team (MDT) to create

overall integrated development strategies that support optimal medicine development for Global as

well as Japan, including Integrated Evidence Plan (IEP) and Medicine Profile. Serves as the asset level

point-of-contact for the central Medicine Development Leader (MDL).

⚫ Acts as a single point of accountability for all aspects of a medicine development in Japan from initiation

of Japan development to launch in Japan. Provide clinical leadership and asset/disease expertise for the

clinical trial program and indications in scope

⚫ Delivers differentiated medicines of value for patients, stakeholders and markets in Japan on time

within budget, through an evidence package that supports regulatory approval, market access, and

product life cycle in Japan.

⚫ Provide Matrix Leadership in Japan (i.e. Japan Medicine Development Team) to ensure integrated

approach, robust planning, and execution oversight. Also supports differentiated development for team

members; owns the performance of J-MDT and partners with line managers to drive performance.

Serves as the single accountable decision maker to resolve disputes among the J-MDT.

⚫ Works closely with the Japan Early Development Leader (J-EDL) as well as Japan Medical Lead (J-MAL)

and Japan Commercial Lead (JCL) to ensure a smooth transition between the J-EDL (accountable from

C2CS to initiation of Japan development) to J-MDL (accountable from initiation of Japan development to

the first approval in Japan) and from J-MDL to J-MAL/JCL (accountable after the first approval in Japan).

⚫ Asset single point of contact and spokesperson to Japan senior management and Japan governance

board (e.g. Portfolio Investment Board Japan).

⚫ Engages with external experts and professional societies to gain insights to design and deliver clinical

development strategy.

⚫ Proactively identifies unmet medical needs that could be addressed through line extensions in Japan.

Prioritizes and maximizes the asset’s portfolio options including developing multiple indications in

Japan.

⚫ Responsible for making recommendations to TAL/IET Leader and senior stakeholders on benefit risk

assessment, Go/No-go criteria, and Clinical PoS for the program in scope

⚫ To create the communication strategy and represent GSK externally and keep good relationship with

Regulatory and government organisations

- Ministry of Health, Labor, and Welfare, PMDA
- Japanese Government (Cabinet minister, Minister office)
- National Center, Researech Institute (National Cancer Hospital etc) Scientific Societies, EEs
- Patient Groups
- CRO

⚫ Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality

of data and science. Ensures excellence in execution of all governance processes, including oversight of

all studies, pharmacovigilance, scientific engagement and promotional practices.

⚫ J-MDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the J

MDL is accountable for managing the asset budget in Japan.

Minimum Level of Job-Related Experience & education

⚫ Master of Science or equivalent.

⚫ MD, PhD, PharmD preferred

⚫ Subject matter expert in neurology, immunology and/or cardiometabolic disease

⚫ Experienced in external engagements with KOLs and professional societies

⚫ Experience with early phase clinical research

⚫ Considerable pharmaceutical industry experience is required

⚫ Experience of working with Japan regulators and regulatory requirements including an understanding of

the legal and government frameworks

⚫ Fluent in Japanese and English

⚫ Great communication and influencing skills

Skills
Agile Thinking, Clinical Development, Clinical Trial Designs, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Project Management, Risk Management, Strategic Thinking, Teamwork, Time Management

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected] . Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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