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Clinical Research Medical Director - Inflammation

Company: Amgen
Location: Thousand Oaks
Posted on: March 17, 2020

Job Description:

The Inflammation Therapeutic Area is seeking a Clinical Research Medical Director for global Phase 2 inflammation program AMG 592, IL2 Mutein. It is being investigated as a treatment for systemic lupus erythematosus, rheumatoid arthritis and Chronic Graft versus host disease. This position is located in Thousand Oaks, California and will have an opportunity to shape the growing Inflammation Therapeutic Area and will report directly to the Global Development Lead for the program. Responsibilities:

  • Serve as the study/indication lead and provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan in for the indication
  • Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Participating and providing clinical input into safety and regulatory interactions
    • Interpretation and communication of 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 Leader
    • Provide clinical content input to:
      • Materials to be used in Scientific Affairs
      • Materials to be used by the Commercial OrganizationBasic Qualifications MD or DO degree from an accredited medical schoolAND2 years of clinical development experience in industryPreferred Qualifications
        • MD with strong and versatile clinical development experience in inflammation: and accreditation in relevant sub-specialty (i.e. lupus/SLE)
        • 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 pathAmgen 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 by 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.MD01#LI-POSTJoin UsIf 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.

Keywords: Amgen, Thousand Oaks , Clinical Research Medical Director - Inflammation, Executive , Thousand Oaks, California

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