※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Japan Medicine Development Leader (JMDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The JMDL serves as the asset level point-of-contact for MDL, and asset single point of contact to Japan senior management and Japan governance board.
- 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.
- 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.
- Leads the multi-disciplinary matrix team in Japan (i.e. Japan Project Team); supports differentiated development for team members; owns the performance of JPT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the JPT.
- Collaborates with the central Medicine Development Team (MDT) to create 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).
- 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 JMDL (accountable from initiation of Japan development to the first approval in Japan) and from JPL 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).
- 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.
- Increases visibility amongst the external communities (physicians, regulators, patients, payers) in Japan, to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of Company.
- 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.
- JMDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the JMDL is accountable for managing the asset budget in Japan.
- Scientific degree or equivalent experience (Area of Specialization: Life sciences, Pharmaceutical, Medical or equivalent)
- Considerable pharmaceutical industry experience is required
- Filing experience, JNDA as a core responsibility and have led development programs and deep experience in all phases of product development, especially in late phase development is preferred
- Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks
- Matrix leadership skills
- Good personality to build collaborative team
- Knowledge/sense for risk management and governance
- Performance focus mindset
- Fundamental business acumen and strategic capability
- Innovative mindset based on scientific curiosity, logical and analytical thinking
- Fluent English proficiency
[Preferred Knowledge, Skills and Abilities]
- Master of Science or equivalent. MD, PhD, PharmD
※Experiences and skills will be considered
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We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.