Japan Medicine Development Lead (J-MDL) Specialty

Site Name: Japan - Tokyo - Akasaka Posted Date: Jan 31 2023 Job Purpose & Key Responsibilities 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 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. Required Skill, Experience, Etc. Previous Experience Required: Minimum level 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. Knowledge/Education Required Minimum Level of Education: Scientific degree or equivalent experience: Life sciences, Pharmaceutical, Medical or equivalent Why is it required?: This role requires a good understanding of scientific and medical information and an ability to apply this understanding to create medicine development strategy as well as execution Preferred Level of Education: Master of Science or equivalent. MD, PhD, PharmD preferred but not essential: Life sciences, Pharmaceutical, Medical or equivalent Why is it required?: This role leads a medicine development in Japan in collaboration with external physicians and regulatory authorities and must be able to intelligently convey GSK positions and requirements to a highly educated external partner group. 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 Preferred Qualification Skill Experience Experience of medicine development leader or matrix team leader Expertise of Hepatology, Immunology, or Infectious Diseases 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.