Global Director, Benefit-Risk Management, Remote – Amgen – Thousand Oaks, CA

Career Category

Safety

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 Director, Benefit-Risk Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you are responsible for providing strategic support for benefit-risk management activities across the product lifecycle for Amgen assets.

Responsibilities:

Establish and maintain processes and training for benefit-risk activities and ensures compliance with global regulations related to benefit-risk assessments. Promote excellence in structured benefit-risk assessment and oversee incorporation of patient perspective/patient focus into benefit-risk activities through the product lifecycle. Ensure benefit-risk assessment processes are continuously improved to reflect best practice, regulatory trends, and guideline. Provide leadership and guidance on benefit-risk assessments to support of product development programs, new product marketing applications and marketed products.

• Serve as the in-house safety benefit-risk expert for all therapeutic areas and provide subject matter expertise on the development of structured benefit-risk assessments

• Develop and maintain respective standards and serves as functional owner of SOPs and associated controlled documents

• Responsible for the robustness of the benefit-risk management process, including tracking and key performance metrics.

• Provide guidance on incorporation of patient perspective/patient focus into benefit-risk activities and deliverables (e.g., patient preference studies)

• Lead and facilitate preparation of a product’s structured benefit-risk assessment with incorporation of cross-functional perspectives.

• Advise on qualitative and quantitative methods for BR assessments, as appropriate.

• Provide guidance on incorporation of real-world data and real-world evidence in the structured benefit-risk assessment as part of filing strategy

• Provide guidance and subject matter expertise to the assigned therapeutic areas on benefit- risk assessment strategies and ensure consistency across Amgen product portfolio

• Train Global Patient Safety staff on benefit-risk assessment concepts and best practices

• Responsible for Structured Benefit-Risk activities budgeting

• Department development and management responsibilities.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Safety professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Drug Safety or Life Sciences experience

OR

Master’s degree and 7 years of Drug Safety or Life Sciences experience

OR

Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience

Preferred Qualifications:

• Masters level degree in health sciences with 8 – 10 years or doctorate degree with 4-6 years of directly relevant experience (including 6 years of experience in Drug Safety) and experience in leading and managing teams

• Demonstrate knowledge of global aspects of pharmacovigilance, risk management, and benefit-risk assessment

• Strong knowledge of processes and global regulations for pharmacovigilance and benefit-risk management

• Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision

• Demonstrated success in navigating a highly matrix-based organization to deliver against complex program plans.

• Working effectively when co-located with and when remote from, product teams/leaders/managers

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.

• 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

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