Amgen · 1 week ago
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
South San Francisco, CA
Full-time
Hybrid
Senior Level, Lead/Staff
5+ years expAmgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. They are seeking a Principal Scientist in Clinical Pharmacology, Modeling & Simulation to drive innovative modeling and simulation strategies that support clinical dosage selections and study designs across various therapeutic areas.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs
Apply Quantitative Translational and Clinical Pharmacology approaches such as PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling integrated with emerging Machine Learning and Generative AI approaches
Guide optimal clinical drug development
Qualification
Required
Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
Master's degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
Bachelor's degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience
Associate's degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience
High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience
Preferred
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
Benefits
A 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
Flexible work models, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
2026-01-16
Company data provided by crunchbase