Amgen

Clinical Research Medical Director - Inflammation

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 29, 2020
Ref
R-95828
Required Education
Bachelors Degree
Position Type
Full time
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 original product.

The Clinical Research Medical Director (CRMD) serves 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 judgement 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


Basic 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)


Amgen is committed to unlocking the potential of biology for patients suffering from serious

illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

This approach begins my using tools like advanced human genetics to unravel the complexities of

disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.