Diagnostic Strategy Heme-Onc - Director

Thousand Oaks, CA, US
Jun 08, 2019
Required Education
Position Type
Full time
Amgen is searching for a Director - Diagnostic Strategy Lead, Heme/Onc. This individual will be responsible for the development and implementation of the In Vitro Diagnostic strategies and will work out of our Thousand Oaks research site.

Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Integral to the ongoing success of Amgen's growing pipeline, the In Vitro Diagnostics (IVD) Group is responsible for the successful transition a biomarker to marketed IVD to support the clinical development strategy for regulatory approval and commercialization. As such, the IVD group works closely with other functions within Amgen to identify the appropriate partner for diagnostic test development. We are looking for individuals with experience in driving end - to - end diagnostic strategies that align to development needs of the therapeutics the diagnostics support. The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of communication expertise across a broad range of stakeholders, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.

The Diagnostic Strategy Lead, Heme/Onc reports to the Executive Director of Diagnostic Strategy and will be responsible for:
  • The end - to - end diagnostic strategy for a therapeutic product team in support of the Heme/Onc portfolio
  • The development and successful implementation of global strategic plans, programs and initiatives to support approval and commercialization of the diagnostic to support the therapeutic needs
  • Working with product teams to develop business cases, strategic evaluation of diagnostic options and diagnostic market landscape assessment
  • Developing the companion diagnostic launch strategy for the product team together with the diagnostic partners and ensure successful execution
  • Ensuring that the diagnostic strategy incorporates global requirements for execution and success
  • Working closely with global and regional marketing teams, and other cross functional partners and stakeholders, to deliver and implement regional and global diagnostic business strategies

Basic Qualifications

Doctorate degree and 4 years of pharmaceutical and/or diagnostic experience
Master's degree and 7 years of pharmaceutical and/or diagnostic experience
Bachelor's degree and 9 years of pharmaceutical and/or diagnostic experience

Preferred Qualifications

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Experience in non-oncology drug development and / or in vitro diagnostics

Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets

Knowledge and experience in clinical trial design

Experience integrating data from multiple sources and identifying critical process variables.

Experience establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying contingency plans.

5+ years of experience in pharmaceutical industry

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.