Principal Scientist, Clinical Pharmacology, Modeling & Simulation

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.

Principal Scientist, Clinical Pharmacology, Modeling & Simulation

What you will do

Lets do this. Lets change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Quantitative Clinical Pharmacology, Modeling and Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T cells-based therapies in addition to small molecule & mono-clonal antibodies.

The Principal Scientist will be Subject Matter Expert who will apply innovative Quantitative Clinical Pharmacology approaches to guide optimal drug development including Pharmacokinetic/Pharmacodynamic (PK/PD) modeling, Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK-Pharmacodynamic (M-PBPK-PD) modeling and Quantitative Systems Pharmacology (QSP) modeling to ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal drug development.

You will apply Model-Based Drug Development and principles of quantitative Clinical Pharmacology to ensure optimal drug development.

This position is based in Amgen, South San Francisco site and candidates that can be based at this site are preferred. Amgen also offers Flexible work models including working from home options and consideration can also be given to qualified remote candidates.

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 leader with these qualifications.

Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience

Or

Masters degree and 5 years of Clinical Pharmacology and Modeling & Simulation experience

Or

Bachelors degree and 7 years of Clinical Pharmacology and Modeling & Simulation experience

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD).
• 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling to inform clinical study designs, optimal dosage selection in target patient populations, characterization of drug-drug interactions, dosing in special populations, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling required.
• Established track-record of Model Based Drug Development (MIDD).
• Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
• Experience in leading the design and implementation of Clinical Pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.

What you can expect of us

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

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 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 accommodation.