|部署・役職名||Science Lead （Autoimmune）, Medical|
Execute Evidence generation strategy in responsible therapeutic area under Medical Affairs Director oversight by closely collaborating with MA members, External experts, EOR （Evidence and Observational Research） team and global counterparts so that the studies are properly planned, delivered and published to address Key Research Questions and unmet medical needs that support Business strategy.
Deliver high－quality scientific and strategic evidence through the company and ESR, with Scientific publications by closely collaborating with internal and external stakeholders.
Support or Supervise medical key messages, Materials for KEE communication, MSL training plans/materials/implementation, and incorporation of MSL insights into Evidence plan in collaboration with MAM/MAD/MSLM/MSLD.
Medical Brand Stratagy
Develop and update evidence generation part assigned by MAD
Ensure quality of information in responsible evidence plan
✓ Data generation strategy
Execute Data generation strategy under MAD oversight by closely collaborating with EOR team.
Provide presentation and lead discussion in ABM/CIM for evidence generation strategy creation.
✓ ESR plan to execution
Review ESR proposals, protocols and publications and provide scientific feedbacks （incl. investigator relations）
Ensure validity of proposal, protocol and impact on medical practice at LREG and GREG.
✓the company plan to execution
Create study design concept（SDC） and represent the responsible TA in the company study team by providing medical/scientific inputs and leading discussions.
Manage progress and budget.
✓ Scientific Publication
Prepare abstracts, manuscripts and presentations and review publications by collaborating with internal/external authors ＆ presenters to execute publication strategy/plans.
✓ Internal training plan to execution
Collaborate with MAM/MAD/MSLM/MSLD to develop internal training plans and materials.
✓ Material Creation
Collaborate with MAM/MAD/MSLM/MSLD to develop Medical Key Messages and TA materials
✓ Knowledge on clinical medicine
Recognized as a clinical medicine expert in the therapeutic area, and is knowledgeable enough to give advice to others
✓Scientific knowledge on the company and related products
Knowledgeable about the company and related products in the therapeutic area, enough to be regarded as an expert by KEE in the therapeutic area
Understand the statistical aspect of articles and company/investigator sponsored studies, and is knowledgeable enough to explain to customers and internal stakeholders
Therapeutic area knowledge
✓Knowledge on patients
Have knowledge on the current status and prospect of Patient（s） Journey and treatment reality in the therapeutic area that is comparable to that of clinicians in the therapeutic area
✓ Knowledge on KEE （for selection）
Have highly accurate information on KEE/Next generation and surrounding environment at global/national level in the therapeutic area, to the extent that one can give advice to other functions
✓ Knowledge on the company, the company's products, competitors, competing products, and patient population
Understand the size/characteristics of patient population in the therapeutic area, and have knowledge to the extent that one can figure out when to take actions as Medical, based on competitors’ brand strategies, scientific strategies （Medical aspect of the strategies）, and regulatory landscape
✓ Proven ability of clinical study planning/execution
Knowledgeable enough to develop difficult NIS plan, review ESR’s SDC/protocol, and manage the progress
＊Example of a “difficult” study: Clinical study on a disease with no guidance/indicator
✓ Knowledge and proven ability of publication work
Familiar with publication related work and knowledgeable enough to explain to others. Systematically organize/accumulate knowledge on publication related media and their characteristics learned from experience, and share the information with others
✓ Knowledge on compliance
Correctly understand overall compliance rules in the industry, and knowledgeable enough to make appropriate business decisions and reflect them into action
✓ Communication skills
By eliciting views and opinions from the other party and understanding agreement/disagreement with the company/own opinions, derive a reasonable agreement or conclusion, and have the other party to take expected actions
✓ Logical thinking
Have logical thinking to deal with a complicated, or seemingly insoluble incidence, based on the big picture of the incidence
✓ Information collection skills
Define necessary information, and collect necessary information efficiently
Speaking skills: Be able to effectively negotiate at work
Reading/writing skills: Correctly comprehend English sentences in a natural speed, and create sentences smoothly
Project management skills: Manage projects and work on one’s own by assuming variable possibilities and risks
【 Education, Qualifications, and Experience 】
Ph.D. in Medical/Life science/Related area or Qualified Medical Doctor
Excellent knowledge of science, disease area and clinical research
Capable of conducting discussions with top－tier experts
Interest in a long－term career in the pharmaceutical industry
Biz level in English/Japanese – speaking ability at level to participate in global working groups
An ability to travel
Qualified Medical Doctor
Experience in Clinical Medicine
Experience of basic or clinical research handling
Advanced English capability
Understanding of multiple aspects within Medical Affairs
Experience of Medical Affairs function within a pharmaceutical industry .