Career Category

Clinical

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.

Indication Team Lead (Senior Manager Study Management )

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the clinical operational strategies, support development of CDPs and oversee the planning and operational execution of multiple early clinical development molecules/programs in phase 0 – 1/2.

The Indication Team Lead is therapeutically aligned (oncology, cardiovascular, inflammation, neuroscience, metabolic disorders) and serves as a consultant and advisor for Global Early Clinical Development Managers (GECDM) and Early Development Leads (EDL) within their respective TA. The Indication Team Lead is accountable for functional management including recruiting and developing a high-quality Early Development team and supports resource planning within their respective TA.

• Lead and oversee the development and execution of the operational strategies for multiple programs within their Early Development respective TA; Provide strategic operational input to program CDPs, TPP (target product profiles) and study designs.
• Lead clinical operations teams to ensure effective development implementation and execution of clinical trials in accordance with SOPs, GCP and regulatory guidance.
• Accountability at indication level, ensuring strategic alignment, consistency, and successful risk mitigation; Building Program/platform/indication expertise with proficiency and consistency; Cross-functional collaboration with key stakeholders and Leaders; Identify strategic business requirements to support their respective indication program needs.
• Participate in KOL engagements; Participates in initiatives to drive department operational strategy and continuous improvement; Manages and develops reports

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of Clinical experience OR
• Master’s degree and 6 years of Clinical experience OR
• Bachelor’s degree and 8 years of Clinical experience OR
• With 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 10+ years work experience in life sciences or medically related field
• 6+ years direct line management experience
• 6+ years of bio-pharmaceutical clinical research experience in early stage program development obtained working in a biotech, pharmaceutical or CRO company
• Degree in science related field
• Previous experience in managing clinical programs
• Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
• Demonstrated success in managing complex early stage clinical program activities. Experience in FIH/phase 1 clinical trial design, regulatory submission package, execution, and reporting of phase I safety / pharmacology studies
• Demonstrated understanding of translational medicine and the complexities and recent developments in FIH adaptive design approaches / clinical pharmacology and the implications for drug development

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

Equal Opportunity Statement

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 a 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 an accommodation.

#GDO2021

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.