Clinical Research Medical Director - Inflammation

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 read over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Live

What you will do

Let's do this. Let's change the world. In this vital role you will serve as a medical expert for the development of biosimilar products at each stage of its clinical development in alignment with the Global Development Lead. The CRMD is an integral cross-functional partner with the Operations, Regulatory Affairs, Clinical Development Operations, Biostatistical, Safety, Scientific Affairs, and other groups.

This role is responsible for:

Supporting the development, execution and communication of the global scientific/medical evidence plan

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

Supporting the development of key scientific external relationships with opinion leaders

Participating and providing clinical input into safety and regulatory interactions

Key Activities

Provide clinical/scientific input during the development and execution of clinical trials

Interpret clinical trial data

Participate in safety assessments

Participate in interactions with regulatory agencies

Author clinical study reports, publications and regulatory submissions

Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL) Support new clinical research opportunities

Support in-licensing and out-licensing activities and partner relationships

Support product lifecycle management as directed by GDL

Knowledge

In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

Familiarity with concepts of clinical research and clinical trial design, including biostatistics

Sound scientific and clinical judgement

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

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

Demonstrated ability as a medical expert in a complex matrix environment

History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Provide clinical content input to:

• Regulatory interactions and documents
• Safety interactions and documents
• Materials to be used in Scientific Affairs
• Materials to be used by the Commercial Organization

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical Research Medical Director professional we seek is a scientific and medical expert with these qualifications.

• MD/DO or equivalent MD degree and 2 years of clinical research experience and/or basic science research

Preferred Qualifications

• MD plus completion of an accredited residency with experience in rheumatology, allergy/immunology or related disease areas
• 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Drug development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

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.

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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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.