Global Medical Affairs Lead, Uplizna

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, Uplizna

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable for the development and execution of global medical affairs strategy for Uplizna.

• Serve as the Medical Affairs Representative on various global strategic teams.
• Support the development of the integrated evidence generation plan for neuromyelitis optica spectrum disorder and other follow-on indications.
• 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 medical 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.
• Cultivate and improve collaboration and coordination across medical functions.
• Lead/support relationships with the external healthcare community.
• Serve as a medical representative in leadership, governance, and cross-functional teams.
• Provide insights to Amgen's Safety and Benefit/Risk profile of the molecule.
• Support evidence generation that shapes the therapeutic area and informs the practice of medicine.
• Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies.
• Review, approve, and ensure dissemination of medical communications and related activities.
• Lead or support advisory boards and other meetings.
• Ensure conduct of medical activities in full compliance with all laws, regulations, and SOPs.
• Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvement.

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 neurologic indications

OR

Master’s degree and 8 years of medical affairs or clinical development experience in inflammation, rare disease, and/or neurologic indications

OR

Bachelor’s degree and 10 years of medical affairs or clinical development experience in inflammation, rare disease, and/or neurologic indications

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

Preferred Qualifications:

• 3 years of clinical research and/or medical affairs experience in a leadership role
• MD plus accredited fellowship in internal medical sub-specialty and/or neurologic indications
• Minimum of 5 years of Medical Affairs experience in industry (biotech, pharmaceutical or CRO)
• 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