Amgen

Senior Scientist - In Vitro Diagnostics

Employer
Amgen
Location
South San Francisco, CA, US
Posted
Jul 16, 2019
Ref
R-74430
Required Education
Bachelors Degree
Position Type
Full time
A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the promise of this emerging science to bring safe, effective medicines from lab, to manufacturing plant, to patient. 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.

Amgen is seeking a Senior Scientist - In Vitro Diagnostics to work out of their South San Francisco, CA location. Integral to the ongoing success of Amgen's comprehensive biomarker programs, the Medical Sciences In Vitro Diagnostics (IVD) Group is responsible for the transition of exploratory biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partner for diagnostic test development. The role uses a wide 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 Senior Scientist is responsible for:

Formulating and implementing companion diagnostic development strategies through integration of functional stakeholder input

Working with third party companion diagnostic partners to develop project plans including resource identification, budget, facility and regulatory requirements to meet project goals and clinical timelines

Leading internal and external cross-functional teams required to manage and execute external diagnostic development partnerships with third parties from inception through regulatory approval in multiple jurisdictions

Basic Qualifications:

Doctorate degree and 2 years of companion diagnostic development experience

OR

Master's degree and 4 years of companion diagnostic development experience

OR

Bachelor's degree and 6 years of companion diagnostic development experience

Preferred Qualifications:

Ph.D

Subject matter expert with proven pharma-facing experience developing and launching companion diagnostics in alignment with drug development programs

Poise and professionalism with strong communication and influencing skills in a dynamic and changing environment

R&D experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets

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 risks and contingency plans

Understanding of clinical study design and operational considerations associated with the alignment of companion diagnostic and pharmaceutical clinical trials

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