Clinical Research Medical Director, Inflammation US- Remote

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, Inflammation

What you will do

Let's do this. Let's change the world. Inflammation and autoimmunity are chronic and sometimes rare diseases with significant unmet medical need. At Amgen we strive to identify new novel targets and mechanisms of action that can demonstrate improved efficacy over established standard of care or without any established standard of care. Amgen has been at the forefront of biologic medicines for inflammation for over 20 years with a robust pipeline that includes tezepelumab, Otezla and several early development first in class novel mechanisms. We continue to evaluate therapeutic options for inflammatory diseases, such as systemic lupus erythematosus, inflammatory bowel disease, respiratory, rheumatologic and dermatologic diseases with fusion proteins, bispecific antibodies and other novel monoclonal antibodies.

The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is in Thousand Oaks, California; however, a remote working arrangement will be considered.

Responsibilities:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication

• 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 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 GDL

• 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

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.

• MD or DO degree from an accredited medical school AND

• Completion of an accredited medical or surgical residency OR

• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

• 2 years of clinical development experience in industry

• MD with strong and versatile clinical development experience in inflammation, and accreditation in relevant sub-specialty (i.e. gastroenterology )

• 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 1,2 and/or 3 clinical trials in inflammation/immunology

• 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

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

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.