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Medical Director, Global Medical Affairs, Rare Disease

Amgen
over 2022 years ago
Remote friendly (United States)
United States
Medical Affairs

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%).