Amgen

Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jul 16, 2021
Ref
R-122319
Required Education
Bachelors Degree
Position Type
Full time

  • HOW MIGHT YOU DEFY IMAGINATION?

    If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

    Principal Scientist - Clinical Pharmacology, Modeling & Simulation

    In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.

    To support that mission, Amgen is seeking a Principal Scientist to work out of our Thousand Oaks locations. This position will report to Director Medical Sciences.

    Live

    What you will do

    Lets do this. Lets change the world. In this vital role you will be a member of cross-functional global drug development teams as the Clinical Pharmacology, Modeling & Simulation department representative. They will act as the Subject Matter Authority who will apply ground breaking Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches to ensure development of safe & effective dosing regimens for various patient sub-populations and also ensure optimal drug development. The Principal Scientist will also be responsible for designing integrated Clinical Pharmacology Modeling & Simulation plans & designing, planning and execution of clinical pharmacology studies in support of these plans.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go getter with these qualifications.

    Basic Qualifications:

    Doctorate degree and 3 years of Pharmaceutical or Biotech experience

    Or

    Masters degree and 6 years of Pharmaceutical or Biotech experience

    Or

    Bachelors degree and 8 years of Pharmaceutical or Biotech experience

    Preferred Qualifications:
  • PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or (MD or PharmD)
  • 5+ years of experience as Clinical Pharmacology Modeling & Simulation functional representative on product development teams in the Biotechnology/Pharmaceutical Industry.
  • Experience in designing strategic integrated 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, Adsorbtion, Distribution, Metabolization, and Excretion (ADME) and pediatric studies and integrating results into regulatory filings, and product labels.
  • Established track record of Model Based Drug Development. Hands-on experience in population PK/PD & PBPK modeling and simulation.
  • Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
  • Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidances
  • Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Apply now

    for a career that defies imagination

    In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

    careers.amgen.com

    Equal Opportunity Statement

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.


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.