Global Medical Affairs Leader, Autoantibody

Role Summary

The Global Medical Affairs Leader (GMAL) Autoantibody is a Director-level individual contributor role responsible for leading certain aspects of the clinical-commercial optimization for asset development and lifecycle management strategies and plans for nipocalimab. S/he will partner closely with the GMA Strategy and Execution team, Regional Medical TA/product leaders and Clinical Development Leader to develop integrated global medical affairs perspectives, strategies and plans.

The GMAL is a member of the Immunology Global Medical Affairs team, partnering with regional medical TA/product leaders to build global medical affairs strategies and plans, and may serve on Safety Management Team(s), Compound Development Team(s) and 3M team(s). The GMAL establishes medical affairs plans reflecting prioritized global/regional needs included in the overall Compound Development Plan and leads global medical affairs strategy, publications, engagement with opinion leaders, advisory boards, and worldwide evidence generation plans.

• Develop medical affairs strategy and plans for the compound (development or marketed) based on prioritized regional needs, aligned with global medical objectives
• Collaborate with regional medical affairs and maintain open, two-way communication to keep plans, progress, and decisions up to date
• Own internal training strategy to educate global and regional market access and medical affairs teams
• Oversee global publications planning process (pre-launch and lifecycle) including manuscripts, abstracts, posters, papers, and pre-launch KOL communications & speaker development
• Review manuscripts/presentations/posters to ensure alignment with strategy and effective communication
• Ensure all global activities follow Johnson & Johnson compliance principles
• Coordinate pre- and post-launch medical activities, medical symposia, and congress activities with regions
• Lead medical education strategy and creation/approval of medical material for external use (e.g., HCP education)
• Manage opinion leader relations and global advisory boards
• Review Medical Information Core Responses for new products
• Participate as a member of Safety Management Team(s), Compound Development Team(s), and Global Commercial Team(s)
• Collaborate with global commercial and market access leaders for marketed products
• Provide medical input into market research and health outcomes research conducted by commercial and market access teams

• An advanced scientific/medical degree (e.g., MD, PhD, Pharm
  
  D) is required
• A minimum of 8 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required
• Medical Affairs experience is required
• Prior global medical affairs experience is highly preferred
• Experience in rheumatology, immunology, or rare disease is highly preferred
• Launch experience is highly preferred
• Established network with medical experts/opinion leaders in rheumatology, immunology, and/or rare disease is preferred
• Ability to work in a matrix environment and understand global complexity is required
• Global mindset and ability to partner cross-culturally/regionally is required
• Knowledge of study/clinical methodology, data reviews and analysis is preferred
• Proven track record leading matrixed, cross-functional teams
• Experience developing and managing relationships with medical experts/opinion leaders
• Ethical decision making and willingness to travel (minimum 25% domestic and international)
• Hybrid work location:
  Horsham, PA with three days in office and two days remote per week