Clinical Research Medical Director, T2D, US - Remote

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.

Clinical Research Medical Director, T2D, US - Remote

Live

What you will do

Let’s do this. Let’s change the world.

The Obesity Therapeutic Area is seeking a Clinical Research Medical Director to play a leadership role on one or more studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this vital role, you will report directly to the Global Development Lead for the assigned indication.

• Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for the maridebart cafraglutide (AMG 133) phase 3 program.

• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program

• Participate and provide clinical input into safety and regulatory interactions

• Interpret and communicate clinical trial data

• Author clinical study reports, publications and regulatory submissions

• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Contribute to TPP (target product profile) and Global Product Safety (GPS) development

• Create development options and present to Global Dev Review Committee (GDRC), Obesity Leadership Team (OLT)

• Interact with TA leadership and extended team to develop options

• Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.

Win

What we expect of you

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

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• Type 2 Diabetes experience

• Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty

• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes

• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 2 and/or 3 clinical trials in diabetes or obesity

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

• Leadership experience/potential as a medical expert in a complex matrix environment

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path

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.

The annual base salary range for this opportunity in the U.S. is $261,969. - $329,723.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans wi