Medical Director, Global Medical Affairs, Rare Disease

Amgen • Thousand Oaks, CA

7d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Medical Affairs Medical Director, Rare Disease What you will do Let’s do this. Let’s change the world. In this vital role you will lead global medical strategy for gMG. 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. Willingness to travel (approximately 30% of travel may be required).

Requirements

• 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 to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• Board-certified physician (MD/DO) with experience in product lifecycle management
• Demonstrated strength in scientific leadership, strategic thinking, and collaboration with cross-functional partners
• Demonstrated experience in leading global launches
• Demonstrated expertise in leading evidence generation initiatives

Responsibilities

• Lead global medical strategy for gMG.
• 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.
• Willingness to travel (approximately 30% of travel may be required).

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree