Clinical Pharmacology Modeling and Simulation Expert

1 month ago


Thousand Oaks, California, United States Amgen SA Full time
Transforming Lives through Innovative Medicine

At Amgen, we are dedicated to serving patients living with serious illnesses. Our mission drives us to research, manufacture, and deliver innovative medicines that help people live longer, fuller, and happier lives.

Job Summary

We are seeking a highly skilled Senior Principal Scientist to lead clinical pharmacology components of multiple clinical programs. The ideal candidate will have a strong background in clinical pharmacology, pharmacokinetics, and pharmacodynamics, with experience in designing and interpreting clinical pharmacology studies.

Key Responsibilities
  • Design and lead clinical pharmacology studies, including study design, protocol preparation, and reporting
  • Integrate results into regulatory filings and product labels, applying PKPD modeling concepts to inform dose selection, study design, and risk/benefit assessments
  • Collaborate with cross-functional teams to develop clinical pharmacology strategies and plans
  • Develop and implement clinical pharmacology standard methodologies
  • Plan and implement PKPD analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses and study designs
Requirements
  • Doctorate degree in Clinical Pharmacology/PKPD or related field, or equivalent experience
  • 3+ years of clinical pharmacology experience, or equivalent experience
  • Broad knowledge of leading and innovative principles and theories in the field, and basic knowledge of related and adjacent disciplinary areas
Preferred Qualifications
  • PhD in Clinical Pharmacology/PKPD, PharmD with a clinical pharmacology fellowship, or equivalent degree in a related field with clinical pharmacology experience
  • 5-10 years of drug development experience with at least 5 years in clinical pharmacology
  • Demonstrated success in managing clinical pharmacology activities and quantitative drug development
What We Offer

As a member of the Amgen team, you will have the opportunity to work on cutting-edge projects, collaborate with talented professionals, and contribute to the development of innovative medicines. We offer a comprehensive benefits package, including a retirement and savings plan, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. We also offer a discretionary annual bonus program and stock-based long-term incentives.

Amgen is an Equal Opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment where everyone feels valued and respected.



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