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.

Biosimilars Clinical Research Medical Director

Live

What you will do

Biosimilars are an important development for Amgen and for patients globally. The opportunity to serve patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen of developing biologics as well as our quality manufacturing capabilities while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product.

Let’s do this. Let’s change the world. In this vital role you will serve as a medical expert for the Biosimilar development 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

Provide clinical content input to:

• Experience with regulatory filing and interactions
• 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 an MD with Drug development experience in the biopharmaceutical industry.

Basic Qualification:

• MD/DO or equivalent MD degree

AND

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

Preferred Qualification:

• MD plus completion of an accredited residency with experience in biosimilars, oncology, hematology, rheumatology, allergy/immunology, gastroenterology, ophthalmology, 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)

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

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.

The annual base salary range for this opportunity in the U.S. is $255,839 – $298,044.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

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

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 cancers, 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.

We will ensure that individuals with disabilities are provided 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 accommodation.