Global Medical Affairs Leader, Autoantibody

Role Summary

The Global Medical Affairs Leader (GMAL) Autoantibody is a Director who will lead aspects of clinical-commercial optimization for asset development and lifecycle management strategies and plans for nipocalimab. The GMAL will partner with the GMA Strategy and Execution team, Regional Medical TA/product leaders and the Clinical Development Leader to develop integrated global medical affairs perspectives, strategies and plans. The GMAL partners closely 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 Global Commercial Team(s). The GMAL is responsible for global medical affairs strategy, global publication plans, global opinion leader engagement, global advisory boards and worldwide evidence generation plans. This position is located in Horsham, PA with a hybrid schedule (three days in the office and two days remotely per week).

Responsibilities

• Responsible to develop medical affairs strategy and plans for the compound (whether in development or marketed) based on prioritized regional needs for assigned regions in alignment with defined global medical objectives
• Collaborate closely with the regional medical affairs and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions
• Responsible for internal training strategy to assure continuous education of global and regional market access and medical affairs teams
• Responsible for global publications planning process oversight (pre-launch and throughout lifecycle) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development
• Review of manuscripts/presentation/posters to ensure alignment with strategy and effective communication/presentation in internal and external audiences
• Responsible to ensure all global activities follow J&J compliance principles
• Responsible for pre- and post-launch medical activities, medical symposia and congress activities in coordination with the regions
• Responsible for medical education strategy as well as creation and approval of medical material for external use (eg. HCP education)
• Responsible for opinion leader relations product/Therapeutic Area global advisory boards
• For new products, will review the Medical Information Core Responses
• The GMAL may act as a member of product Safety Management Team(s) (SMT), Compound Development Team(s) (CDT) and Global Commercial Team(s) (GCT)
• For marketed compounds, collaborate closely with global commercial and market access leaders
• Responsible to provide medical input into market research and health outcomes research conducted by commercial and market access teams, respectively

Qualifications

• An advanced scientific/medical degree 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 highly preferred
• Prior global medical affairs experience is highly preferred
• Experience in neurology/rare disease is highly preferred
• Launch experience is highly preferred
• Having an established network with medical experts/opinion leaders in neurology is preferred
• Ability to work in a matrix environment and understands global complexity is required
• Global mindset and ability to partner cross culturally/regionally is required
• In-depth knowledge of study/clinical methodology, study/clinical data reviews and analysis is preferred
• A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders is required
• Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred
• Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
• Proven track record of ethical decision making is required
• A minimum of 25% domestic and international travel is required
• This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week

Skills

• Medical Affairs, Strategic Thinking