Principal Scientist - Clinical Pharmacology
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 PharmacologyLive
What you will do
Lets do this. Lets change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
The Principal Scientist of Clinical Pharmacology will be responsible for the development and implementation of the Clinical Pharmacology and Modeling Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, antibody-drug-conjugates, CAR-T cells, oncolytic virus & listeria based immunotherapies in addition to small molecule & mono-clonal antibodies. The Principal Scientist will be a member of cross-functional global drug development teams as the Clinical Pharmacology, Modeling & Simulation department representative & will be Subject Matter Authority who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches to ensure development of safe & effective dosing regimens for various patient sub-populations & 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 [vital attribute] professional we seek is a [type of person] with these qualifications.Basic Qualifications:
Doctorate degree and 3 years of Pharmaceutical or Biotech experienceOr
Masters degree and 6 years of Pharmaceutical or Biotech experienceOr
Bachelors degree and 8 years of Pharmaceutical or Biotech experiencePreferred Qualifications:
- PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or (MD or PharmD)
- 8 years 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, 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 guidance.
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
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.comEqual 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 UsIf 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.