Japan Medicine Development Lead

21時間前

Minato 711 GlaxoSmithKline K.K. Full time

職務の目的および主な業務内容 Job Purpose & Key Responsibilities

職務の目的

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.

主な業務内容

  • 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 GSK.
  • 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.

    • ※Future scope of job and working location will be determined by company.

    必要要件 Required Skill, Experience, Etc.

    必要な条件

    スキル

  • 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

    • 経験

  • Considerable pharmaceutical industry experience is required (or, for MD, considerable experience as a leading member in clinical research)
  • 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 (or, for MD, experience as an investigator in Phase 2-3 clinical trials)
  • Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks (not mandatory for MD)

    • 学位/資格/語学力

  • Scientific degree or equivalent experience (Life sciences, Pharmaceutical, Medical or equivalent)
  • Fluent English proficiency

    • 望ましい条件

    スキル

  • Knowledge in Respiratory, Immunology/Inflammation, or Hepatology

    • 学位/資格/語学力

  • Master of Science or equivalent. MD, PhD, PharmD preferred but not essential (Life sciences, Pharmaceutical, Medical or equivalent)

    • Why GSK?

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

    GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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