Medical Advisor / Non-line manager / Emerging Areas Med Affairs Grp

Basic purpose of the job

To contribute to execute CDMA (Clinical Development Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of clinical development and late stages of commercialization.

Accountabilities

・Strengthen value of our pipeline assets by providing medical/scientific robust guidance in the responsible therapeutic area in collaboration with BI Global and other departments.

・Ensure and support Japanese submission and registrations in the respective products from medical affairs perspectives, collaborating with regulatory/ clinical development team.

・Support our company make informed decisions on evidence building activities based on the allocated resources and budget in the therapeutic area and in alignment with brand/asset strategy.

・Prepare Integrated Customer Plan (ICP) to address Japan specific needs, together with Marketing and Market Access & aligned with Global Brand Plan (GBP).

・Build new scientific evidence by collaboration with external experts through clinical/pre-clinical research, external collaborative research and RWE (Real World Evidence) studies.

・Contribution to benefit/risk evaluations and value proposition of assets/brands.

・Gain insight from external experts in working with MSL (Medical Science Liaison) and propose medical strategy.

Regulatory and / or Organizational Requirements

Contribute to strategy and activity review meetings. Ensure ethics and compliance. Plan strategically to allow for effective, safe & medically sound global preparation of drug commercialization efforts. Provide input and medical review of all internal and external documentation prepared by Marketing and Public Relations. Define studies needed to answer relevant clinical/scientific questions regarding our products. Provide medical strategic input to the related development projects to meet regulatory, pricing and access requirements and our launch readiness need, by representing Medical Affairs in the Local Evidence Team.

Job Complexity

・Works in a cross-functional team including MSL, CPL(Clinical Program Lead), RA (Regulatory Affairs), PSPV (Patient Safety & Pharmacovigilance), BDS (Biostatistics & Data Sciences), Marketing, Real Word Evidence/Epidemiology, HEOR (Health Economics and Outcome Research) and Market Access. Requires driving cross-functional projects.

・Plays a key role in planning and leading medical strategy initiatives in collaboration with internal and external stakeholders.

Interfaces

Asset/Brand team, Local/Global R&D team members, Medical Affairs team, Global epidemiology, etc.

Job Expertise

・Full understanding of compliance requirement in Medical Affairs

・Expertise in people management is valued, but not mandatory. Capability to lead project teams or work independently in planning and executing medical strategies is essential.

Minimum Education/Degree Requirements

Master's degree in life sciences. MD or PhD is preferred.

Required Capabilities (Skills, Experience, Competencies)

・Capability to conceptualize research projects, conduct basic and/or clinical research independently, and write scientific papers

・TA experience in clinical or research setting,  ideally in ophthalmology, particularly in vitreoretinal diseases

・Experience in product launch are preferred

・Experience collaborating with and managing key opinion leaders and external experts in relevant disease areas

・Strong negotiation and communication skills for both internal and external stakeholders, in Japan and globally

・Excellent project management and cross-functional collaboration skills, with the ability to work in global matrix teams

・Experience leading team projects (evidence generation, medical strategy, new drug launch/approval, collaboration with external stakeholders); people management experience is preferred.

・English proficiency (at least TOEIC >800)

・Knowledge of regulations related to clinical research, clinical trials, and clinical development

Regarding publications
・Please submit publication's title and Author.