Amgen Global Medical Affairs Lead, Medical Affairs – Oncology Diagnostics and Biomarkers in Thousand Oaks, California
The Oncology Diagnostics (Dx) and Biomarkers Global Medical Affairs Lead (GMAL) is accountable for the development and execution of global medical affairs diagnostics and biomarkers strategy for Amgen’s Oncology 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 Oncology Dx and Biomarkers GMAL will:
Collaborate with relevant product GMALs and cross-functionally to develop the medical affairs strategy for Dx/biomarkers
Partner with regions and countries to execute Dx and biomarker strategy
Lead Scientific Advisory boards and other meetings with Opinion Leaders
Conduct individual Opinion Leader and Pathologist interactions
Lead the medical Dx/biomarker strategy around major oncology congresses
Review Investigator sponsored study (ISS) proposals and other types of research proposals concerning Dx/biomarker
Interact with professional societies and advocacy groups for coordination of activities around Dx/biomarker education and awareness
Support partnerships for Launch Preparation and Post-launch activities
Participate in Dx 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
MD/DO degree from an accredited medical school OR PhD OR PharmD
4 years of Medical Affairs experience or related pharmaceutical industry experience
Strong foundation in Life Sciences e.g. Molecular Biology, Genomics or Oncology
MD plus accredited fellowship in Oncology or Pathology
Experience with oncology clinical biomarker development, 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
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.