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

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Jun 13, 2019

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Job Details

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

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 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.

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Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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