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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. Join us.

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 strategies including US launch and lifecycle manage.

Asset Lead Medical Director

Responsibilities:

• Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team, Portfolio Governance and alignment with Global strategy

• Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global

• Supporting clinical trial conduct

• Participating in engagement of external key stakeholders

• Participating in development of data communication strategy

• Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data

• Supports implementation of Medical governance for respective product, which includes:

• Safety and pharmacovigilance as a key and effective partner with GRAAS

• Clinical trial conduct

• US risk management/minimization in collaboration with GRAAS

• Subject matter appropriateness (medical/scientific) of external interactions (e.g.  copy review, multichannel, congresses, 1-1 interactions, etc.)

• Ensuring appropriate medical support of compliance

Key Activities:

• Maximizes Amgen‘s value proposition of  respective product(s) through management and delivery of all medical and scientific activities , including  launch and lifecycle management, in alignment with Global strategy and Evidence Generation Team (EGT)

• Participates in development of US cross functional strategy and supports medical execution.

• Provides input into medical and scientific insight for incorporation into US product strategies, via the US Medical Plan, and provides insights into Global strategies, plans and tactics as a participant in the Commercialization process

• Executes product-specific US evidence generation strategy, in alignment with EGT, and supports execution of data communication strategy

• Supports product-specific US clinical trial execution

• Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P

• Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data

• Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders

• Participates in advocacy from a medical perspective in partnership with Commercial, Government Affairs and GRAAS policy

• Builds Amgen‘s reputation as a science-based and patient-focused reliable partner

• Ensures human subject safety for marketed product in cooperation and effective partnership with responsible functions (e.g., GRAAS, Global Development)

Win

What we expect of you

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

Basic Qualifications

MD or PhD

2-4 years of medical affairs experiences or clinical development experience; 1-2 of which should be from a pharmaceutical or biotechnology company

Preferred Qualifications

• MD plus accredited fellowship in respective product, board certified or eligible

• PhD with extensive in the cardiometabolic space

• Clinical research/medical affairs experience in biopharmaceutical or CRO industry

• Familiarity with US health care compliance considerations

• Experience with opinion leader interactions, publications planning, data generation activities, and promotional review

• Experience with integrated delivery networks, accountable care organizations, and payers

• Broad and formal leadership experience

Thrive

What you can expect of us

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

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.