Career Category

Job Description

The Department of Clinical Immunology within the Clinical Development Organization at Amgen is seeking a highly motivated Senior Scientist to provide clinical immunogenicity support for our therapeutic pipeline. This position can be fully remote or based in Thousand Oaks, CA. In this role, the individual will provide project and scientific oversight for the immunogenicity component of drug development, covering a diverse portfolio of Amgen product candidates including innovative proteins, siRNAs, and biosimilars. In addition, he/she will work closely with Clinical Development team members across sites and functions including Safety, Biomarkers, Toxicology and Bioanalytical as well as Therapeutic Discovery.

Position Responsibilities

-Author key regulatory, clinical study, and technical documents

-Interpret immune response data and assess potential clinical impact

-Apply immunology expertise throughout the drug development process

-Ability to work independently and manage productive cross-functional collaborations

Basic Qualifications

Doctorate degree OR Master’s degree and 3 years of experience OR Bachelor’s degree and 5 years of experience
AND
Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work in a role
AND
Basic knowledge of related and adjacent disciplinary areas.

Preferred Qualifications

-Ph.D and research/industry experience in the field of immunology

-In-depth understanding of the innate and adaptive immune system, excellent scientific thinking and problem solving

-Detailed knowledge of immunology and various bioanalytical assays used to measure the immune response

-Experience in the clinical development of biologic drugs or vaccines

-Knowledge of immunogenicity risk assessment related to quality attributes

-Familiar with global regulatory guidelines related to immune assessment

-Excellent communication skills and ability to influence and lead cross-functional teams

-Strong verbal and written communication skills

-High degree of flexibility to adapt to different projects and shifting priorities

Salary Range