Senior Clinical Pharmacology Modeling & Simulation Leader

Biopharma Careers; Thousand Oaks (CA); On-site; USD 148,000 - 200,000; Full time

Job summary

Amgen is seeking a Principal Scientist to lead clinical pharmacology modeling and simulation across development programs, guiding dose selection and study design. You will work with pharmacometrics, biostatistics, regulatory affairs, and clinical teams to translate data into clear, regulatory-ready decisions.

You will influence program strategy and contribute to regulatory submissions and labeling with robust PK/PD analyses and population modeling. This on-site role is based in Thousand Oaks, CA.

Qualifications

• Doctorate degree or equivalent in a scientific field.
• MD/PhD/PharmD with post-doctoral experience or equivalent.
• Advanced degree with demonstrated clinical pharmacology experience.

Responsibilities

• Serve as the clinical pharmacology lead for development programs, providing scientific and strategic leadership from early development through registration and post-approval.
• Develop integrated clinical pharmacology plans addressing PK/PD, exposure–response, and dose/regimen selection.
• Design and oversee clinical pharmacology components of programs (FIH, DDI, BA/BE, pediatrics, etc.).
• Lead FIH dose/escalation decisions by integrating nonclinical data and PK/PD.
• Contribute to regulatory submissions, health authority interactions, and product labeling with pharmacology input.
• Collaborate with pharmacometricians, statisticians, clinicians, and regulatory colleagues to ensure timely, high-quality deliverables.
• Communicate complex quantitative concepts clearly to influence program strategy.

Skills

Scientific leadership

Cross-functional collaboration

Written and verbal communication

Regulatory awareness

Data interpretation

Education

PhD

PharmD

MD

Master's degree

Bachelor's degree

Job description

Amgen is seeking a Principal Scientist to lead clinical pharmacology modeling and simulation across development programs, guiding dose selection and study design. You will work with pharmacometrics, biostatistics, regulatory affairs, and clinical teams to translate data into clear, regulatory-ready decisions.

You will influence program strategy and contribute to regulatory submissions and labeling with robust PK/PD analyses and population modeling. This on-site role is based in Thousand Oaks, CA.