US Medical Lead, Medical Affairs - Oncology Biomarkers and Companion Diagnostics

Thousand Oaks, CA, US
Apr 16, 2019
Required Education
Position Type
Full time
The US Medical Lead (USML) Oncology Biomarkers and Companion Diagnostics (cDx) is accountable for the development and execution of US medical affairs biomarkers and cDX strategy for Amgen's Oncology pipeline portfolio of assets across diagnostic technology platforms and tumor types.

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

The US Medical Affairs Lead Oncology Biomarkers and Companion Diagnostics will:
  • Collaborate with relevant pipeline USMLs, cross-functionally and with Global to develop the US medical affairs strategy for biomarkers and cDx
  • Partner with Global and cross-functional partners to execute the US 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 US 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 US Launch Preparation and Post-launch activities
  • Facilitate and continue to build Amgen's role as a science-based, patient-focused partner
  • Determine resource and budget allocation necessary to deliver on US medical strategy

Basic Qualifications

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


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 culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.