Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Overview

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas — Oncology, Inflammation, General Medicine, and Rare Disease — we reach millions of patients each year.

As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

What You Will Do

Lets do this. Lets change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist. In this vital role, you will drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs. Your impact will extend across therapeutic areas such as oncology, rare diseases, obesity, and cardiovascular disease, and spans diverse modalities from small molecules and mAbs to innovative novel modalities.

The Principal Scientist will be a Subject Matter Expert who will apply Quantitative Translational and Clinical Pharmacology approaches such as PK/PD modeling, Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK-PD modeling, Quantitative Systems Pharmacology (QSP) modeling, integrated with emerging Machine Learning and Generative AI approaches to innovatively guide optimal clinical drug development.

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.

Basic Qualifications

Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Masters degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Bachelors degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Associates degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience
Or
High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience

Preferred Qualifications

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, Pharm
  
  D).
• 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 your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we…