Scientist - Clinical Pharmacology Modeling and Simulation

Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Scientist in the Clinical Pharmacology Modeling & Simulation Department within Medical Sciences. The individual will be responsible for the designing, planning and execution of clinical pharmacology strategies & studies in support of development of small and large molecule drugs & cutting-edge novel modalities.

Basic Qualifications

• Doctorate degree

OR

• Master's degree and 4 years of Biotechnology/Pharmaceutical Industry experience

OR

• Bachelor's degree and 6 years of Biotechnology/Pharmaceutical Industry experience

Preferred Qualifications

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or equivalent professional degree (MD or PharmD)
• 3 years of experience as Clinical Pharmacology functional representative on product development teams in the Biotechnology/Pharmaceutical Industry.
• Experience in designing strategic clinical pharmacology, modeling & simulation plans in support of development of small molecule and/or protein therapeutics.
• Experience in leading the design and execution of clinical pharmacology studies including bioequivalence, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
• Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
• Hands-on experience in population PK/PD & PBPK modeling and simulation.
• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances, and experience of interaction with global health authorities.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.