Career Category

Clinical Development

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.

Clinical Research Medical Director - Oncology

Live

What you will do

Let’s do this. Let’s change the world. Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types. In this vital role you will:

• Contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities
• Lead the design and development of clinical study protocols
• Serve as a member of the Clinical Study Team - Leadership Team (CST-LT) to provide oversight and execution of clinical trials.

Responsibilities

• Provide medical and scientific leadership for design of clinical studies and contribute to trial execution from Phase 2 through life-cycle management
• Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication.
• Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP).
• Monitor, analyze, and interpret clinical study data as a Global Development Representative
• Identify and evaluate new clinical research opportunities
• Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents

Win

What we expect of you

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

Basic Qualifications

Doctorate or MD and 4-5 years of clinical research experience and/or completion of an accredited medical or surgical residency

Or

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Medical Doctor or Ph.D.

Preferred Qualifications

• MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent
• Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Previous management experience

Knowledge

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
• Medical knowledge in the relevant therapeutic area
• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Understanding of new drug commercialization and business practices

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.

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