Amgen

Diagnostic Strategy Lead, Non-Oncology - Director

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-76261
Required Education
Bachelors Degree
Position Type
Full time
We are building upon our solid non-onc 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, Non-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 Non-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, Non-Oncology will be responsible for:

The end-to-end diagnostic development strategies for therapeutic product teams within the Non-Oncology therapeutic areas

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 plan

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.

Join Us

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.