Medical Scientific Manager, Japan

The Role

The Medical Scientific Manager, Japan will be a Japan Medical Affairs Team member and will work across several therapeutic areas to implement novel study design approaches to generate robust evidence to enhance understanding of disease epidemiology and natural history, unmet medical need; endpoint selection for Clinical studies; and inform clinical practice on appropriate use and long term safety and effectiveness of Biomarin products post marketing. His/her evidence generation work shall contribute to not only advancement of medical practice in Japan, but also have global impact. The Medical Scientific Manager, Japan will work collaboratively with their Japan colleagues within Worldwide Research and Development, i.e., Medical Affairs, Regulatory, Pharmacovigilance, Study Operation, and commercial teams including market access, as well as liaison with therapeutically aligned Global counterparts in the Global Medical Evidence Generation Team.

This role reports to the Japan Medical Affairs Country Lead.

Key Responsibilities

• Support the implementation of observational research studies and Phase IIIb/IV interventional studies in Japan in-line with a product’s Integrated Evidence Plan
• Provide scientific input into development and reporting of post marketing safety studies in the Japanese setting (post marketing surveillance (PMS) /Use Results Survey) as well as effectiveness studies to address clinical practice evidence gaps and market access specific gaps
• Collaborate closely with Japan Study Operations to ensure successful implementation of Medical Affairs-led studies and PMS studies
• Ensure adequate medical monitoring oversight of Medical Affairs and PMS studies
  • Monitoring and arbitration on subject eligibility
  • Conduct data review to ensure that the data are correct and presented with the appropriate interpretation
  • In collaboration with PV, review and analyze SAEs, safety and effectiveness (as applicable) trends on an ongoing basis; ensure accurate AE and concomitant medication coding (per the study specific Medical Monitoring Plan)
  • Participate in key Database Lock (DBL) activities (final listing review, review of tables, listings and graphs (TLGs), etc.) and actively participate in all data snapshots taken (not limited to final DBL)
  • Responsible for identification, resolution, and escalation of risks, issues, and trends
  • Provide the medical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings; audit reports; clinical study reports; inspection readiness activities, and other key study deliverables
• Provide scientific input in preparation of regulatory submissions, responses to regulatory queries, IRB/Ethics Committee questions, and in preparation for program regulatory inspections and audits

Desired Experience

• Medical Degree or advanced degree in life or health sciences or Epidemiology (e.g. PhD/PharmD/RN)
• 3+ years of clinical trial or post-marketing trial experience either at a study site (eg, investigator, study coordinator), within the biopharmaceutical industry or within a Contract Research Organization. Either work in clinical development or medical affairs is acceptable.
• Prior experience designing and conducting post marketing surveillance (PMS) /Use Results Survey studies in Japan
• Prior experience conducting studies with Real World Data (RWD) assets (e.g., claims, electronic health records, disease registries, and/or surveys) in Japan is plus, but not mandatory.
• English and Japanese language skills (written and oral) at least at conversational level are essential.

Technical competencies

• Knowledge of the clinical research process and Good Clinical/Pharmacoepidemiology Practice standards, clinical study related Japanese regulations and requirements relating to conducting research and disseminating of scientific information.
• Familiarity with Japan Good Post-Marketing Study Practice (GSPS) guidance
• Application of Pharmacoepidemiology research methods designs
• Understanding of statistics and data analysis, ability to interpret study findings
• Scientific writing and document development
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings
• English and Japanese language skills (written and oral) at least at conversational level are essential.

In terms of the performance and personal competencies required for the position, we would highlight the following:

 Collaboration

• Self-motivated with the ability to develop credibility with colleagues and interact effectively
• Experience in collaborating with internal and external research partners on a local and global level
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively
• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive

Executing for Results

• Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills
• Viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization