Diagnostic Strategy Lead, Oncology - Director

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Amgen is searching for a Diagnostic Strategy Lead, Oncology - Director.

This individual will be responsible for the development and implementation of the In Vitro Diagnostic strategies and will work out of our Thousand Oaks or South San Francisco research sites.

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 of a biomarker assay 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 partners for diagnostic test development. We are looking for individuals with experience in driving end - to - end diagnostic development strategies and development life cycle management plans that align to development needs of their corresponding precision therapeutics within the Oncology therapeutic area. The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of technical and business 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, Oncology is responsible for:

The end-to-end diagnostic development strategies for therapeutic product teams within the Oncology therapeutic area
The development and successful implementation of global strategic diagnostic development life cycle plans, programs and initiatives to support approval and commercialization of diagnostics which will support the therapeutic life cycles
Developing business cases, driving the strategic evaluation of diagnostic development options and technologies, diagnostic market landscape assessment
Working with key cross-functional stakeholders to integrate diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful execution of the overall strategy
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
OR
Master's degree and 7 years of pharmaceutical and/or diagnostic experience
OR
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 oncology drug development and / or in vitro diagnostics development
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

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 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.