Clinical Research Medical Director, Rheumatology Rare Disease

Career Category

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

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)
• Participate and provide clinical input into safety and regulatory interactions.
• Interpret and communicate clinical trial data.
• Author/review CSRs, 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.
• Identify new clinical research opportunities.
• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead
• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
• This is a potential managerial role, successful prior experience seeking and developing talent is a plus.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic 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:

• MD with strong and versatile clinical development experience in Rheumatology or Nephrology, and accreditation in relevant sub-specialty
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development …