- Senior Manager Medical, Clinical & Scientific Affairs
・Build and improve Medical Affairs functional capabilities, implement process and procedure to serve business compliantly (to ARDx quality system), effectively and efficiently
・Work with Medical Affairs, Clinical Affairs, Scientific Affairs, Global Marketing, and R&D to assess emerging and/or unmet needs in the developed markets, provide rationales for new product introduction and on market product sustenance, evaluate opportunities for product improvements, innovative ideas and disruptive technologies
・Liaison with senior KOL medical professionals to develop and execute alignment with Commercial Organization
・Advisory Board Management: Initiate and lead development and execution of Scientific Advisory Board Meetings to work on current and future diagnostic guidelines
・Investigator Sponsored Studies Management: manage ongoing studies and develop new studies with Japanese KOL scientific community
・Formulate publications plans at scientific meetings and through journal articles
・Monitoring of Scientific publications: ensures monitoring focus of products important to the business. Drive team to educate sales force on scientific literature and value-based messaging
・Approve speaker slides to support KOLs at major conferences so as to ensure that they are on-label and meet with current guidelines
・Responsible for medical affairs activities for approval and launch of new products; reimbursement and health economic outcome research.
・Lead Medical, Clinical & Scientific Affairs team: define objectives, staff responsibilities, team and personal goals to ensure goal achievement. Define and monitor performance standards, coaching and mentoring as appropriate. Motivate staff by appropriate reward and recognition of major achievements.
・Must comply with and enforce all Office of Ethics and Compliance guidelines.