Global Medical Affairs Lead - Tavneos

Career Category

Medical Affairs

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Medical Affairs Lead - Tavneos

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the single point of Medical accountability for Tavneos for ANCA-associated vasculitis (GPA/MPA). The GMAL drives the development and execution of product Medical strategies to maximize Amgen's value proposition in alignment with product strategies across relevant geographies. This role will be a key part of the Medical Affairs Inflammation Senior Leadership Team reporting to the Vice President, US Medical Affairs Inflammation Therapeutic Area Head.

• Leads Global Medical Affairs strategies/activities/development related to Tavneos, partnering with cross-functional leaders in Global Development, Commercial, and other functions to develop Amgen’s overall strategy.
• Serve as the Medical Affairs Representative on various global strategic teams, including Product Teams and the Evidence Generation Team.
• Support the development of the integrated access and use evidence generation plan for Tavneos.
• Capture clinical/scientific insights across all key markets and translate them into concrete strategies.
• Facilitate scientific engagements across a broad range of partners (e.g. KOLs, Professional Organizations, Payers, Regulators)
• Align and implement strategy for scientific communications and related activities.
• Develop medical strategic plans and ensure consistent execution of outputs through Medical Affairs Teams.
• Provide strategic direction for study design and execution for medical affairs and other global studies.
• Enable access to medicines through clear understanding and education of treatment value.
• Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner.
• Provide input to Value Dossiers.
• Determine resource and budget allocation necessary to deliver on medical strategies.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of medical affairs or clinical development experience in inflammation, rare disease, and/or vasculitis

OR

Master’s degree and 7 years of medical affairs or clinical development experience in inflammation, rare disease, and/or vasculitis

OR

Bachelor’s degree and 9 years of medical affairs or clinical development experience in inflammation, rare disease, and/or vasculitis

Preferred Qualifications:

• 5 years of clinical research and/or medical affairs experience in a leadership role
• MD plus accredited fellowship in Rheumatology or related medical discipline, board certified or board eligible
• Clinical and disease knowledge base in Inflammatory diseases
• Experience in building Integrated Evidence Generation Plans
• Ability to establish interactions and engagements with partners (e.g., Opinion Leaders, advocacy groups, patients, payers, vendors)
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
• History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
• Good understanding of healthcare systems around the world (e.g. US, EU, Asia)
• Track record of success working with matrixed cross-functional teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans