Japan Medicine Development Lead - 製薬企業

勤務地 東京都
雇用形態 正社員
給与 ¥13000000.00 - ¥17000000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 臨床試験 / CRA / CRC,
お問合せ Hidetoshi Sato
JOB ID JO-2210-475079

MANDATORY
・Applicants must have permission to work in Japan
・Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑外資系企業 ☑英語力が必要 ☑リモートワーク可能 ☑フレックス勤務

[ポジション]
Japan Medicine Development Lead

[事業内容・会社の特徴]
外資系製薬企業

[仕事内容]
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 MDL, and asset single point of contact to Japan senior management and Japan governance board.

Key Responsibilities:

  • 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 Medicine Development Team); 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.
  • 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 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).
  • 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 the 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.
  • J-MDL 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.

[応募資格]
Knowledge/Education Required
Minimum:
Scientific degree or equivalent experience
Area of Specialization
Life sciences, Pharmaceutical, Medical or equivalent

Preferred:
Master of Science or equivalent. MD, PhD, PharmD preferred but not essential
Area of Specialization
Life sciences, Pharmaceutical, Medical or equivalent

Previous Experience Required
Minimum:
・ 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
Why is this level of experience required?
This role leads the multi-disciplinary matrix team in Japan to delivers differentiated medicines of value for patients, stakeholders and markets in Japan. Due to the complexity, these experiences are key to gain approval of medicine with high value.

List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
・ 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

[勤務地]
東京都/リモートワーク制度あり

[勤務時間]
フレックス制度あり

[給与]
1300〜1700万円(スキル・ご経験により決定)

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Reference: JO-2210-475079
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Science, Other