Amgen

Global Medical Affairs Lead - Oncology Biomarkers and Companion Diagnostics

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 16, 2019
Ref
R-74761
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Global Medical Affairs Lead (GMAL) Oncology Biomarkers and Companion Diagnostics (cDx) is accountable for the development and execution of global medical affairs biomarkers and companion diagnostics strategy for Amgen's Oncology pipeline portfolio of assets across diagnostic technology platforms and tumor types.

The Global Medical Affairs Lead will work closely with cross-functional partners, regions and countries for coordination of biomarker diagnostic activities.

The Global Medical Affairs Lead (GMAL) Oncology Biomarkers and Companion Diagnostics will:

  • Collaborate with relevant pipeline GMALs and cross-functionally to develop the medical affairs strategy for biomarkers and cDx
  • Partner with regions and countries to execute biomarkers & cDx strategy
  • Lead Scientific Advisory boards and other meetings with Opinion Leaders
  • Conduct individual Opinion Leader and Pathologist interactions
  • Lead the medical biomarker strategy around major oncology congresses
  • Review Investigator sponsored study (ISS) proposals and other types of research proposals concerning biomarkers and diagnostics
  • Interact with professional societies and advocacy groups for coordination of activities around biomarker education and awareness
  • Support partnerships for Launch Preparation and Post-launch activities
  • Participate in Diagnostic Development Team meetings for relevant programs
  • Facilitate and continue to build Amgen's role as a science-based, patient-focused partner
  • Determine resource and budget allocation necessary to deliver on global medical strategy


Basic Qualifications

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

4 years of Medical Affairs experience or pharmaceutical industry experience

Preferred Qualifications
  • MD plus accredited fellowship in Oncology or Pathology
  • Strong foundation in Life Sciences e.g. Molecular Biology, Genomics or Oncology
  • Experience with oncology clinical biomarker development, companion diagnostic development or Next Generation Sequencing platforms
  • 5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Experience with stakeholder engagement and interactions ( e.g. , OLs, advocacy groups, payers)
  • Familiarity with global regulatory organizations, guidelines, and practices
  • Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
  • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
  • History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
  • In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale
  • Track record of success collaborating in matrixed cross-functional teams
  • Outstanding written and verbal communication skills


Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.

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 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.

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