Role Summary
Lead global medical strategy for generalized myasthenia gravis (gMG) as part of Amgen's Rare Disease portfolio. Provide medical leadership and strategic direction for inebilizumab and CD-19–mediated diseases; drive global evidence generation and product lifecycle activities. Collaborate with cross-functional partners to align medical affairs strategy with broader organizational objectives and patient needs.
Responsibilities
- Provide global medical leadership and strategic direction for inebilizumab in generalized myasthenia gravis (gMG).
- Serve as a subject matter expert in gMG, keeping up to date with the latest research and scientific advancements.
- Contribute to global product lifecycle management, serving as a scientific expert on inebilizumab and CD-19 mediated diseases.
- Lead or support the design, execution, and oversight of global evidence generation efforts, including real-world evidence (RWE) studies and clinical development programs.
- Serve as the global medical affairs representative on cross-functional teams, providing strategic insights and support to the Global Medical Affairs Lead (GMAL).
- Collaborate with internal cross-functional partners, including Clinical Development, Marketing, and Access, to align the global medical affairs strategy with broader organizational objectives and pipeline strategy.
- Translate scientific and clinical insights into actionable strategies that address unmet medical needs in rare diseases.
- Lead the planning and execution of medical advisory boards, scientific congresses, symposia, and other scientific engagement activities to generate insights and inform strategic medical plan.
- Establish and maintain strong relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), patient advocacy organizations, and professional societies in the rare disease therapeutic area.
- Ensure high-quality dissemination of clinical and scientific data through peer-reviewed publications, congress presentations, and other medical communication channels.
- Provide medical input to support value dossiers and health economics and outcomes research (HEOR) activities.
- Collaborate with commercial teams to provide scientific input into promotional materials, marketing campaigns, and training programs, ensuring compliance with regulatory and ethical standards.
- Ensure all medical affairs activities adhere to relevant laws, industry regulations, and internal company policies.
- Actively contribute to cross-functional initiatives aimed at shaping the healthcare ecosystem by enabling access through evidence generation, scientific exchange, and medical education.
- Champion a culture of ethical conduct, scientific rigor, and integrity within the organization.
- Maintain accurate and timely documentation of medical affairs activities through global tracking systems.
- Foster Amgen’s reputation as a science-driven, innovative, and patient-centered organization.
Qualifications
- Required: Doctorate degree and 4 years of medical affairs experience; OR Master’s degree and 8 years of medical affairs experience; OR Bachelor’s degree and 10 years of medical affairs experience. In addition, at least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Managerial experience may run concurrently with the required technical experience.
- Preferred: Board-certified physician (MD/DO) with experience in product lifecycle management.
- Preferred: Demonstrated strength in scientific leadership, strategic thinking, and collaboration with cross-functional partners.
- Preferred: Demonstrated experience in leading global launches.
- Preferred: Demonstrated expertise in leading evidence generation initiatives.
Additional Requirements
- Willingness to travel (approximately 30%).