Lead Clinical PK/PD Modeling & Simulation

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Stock-based incentives

Flexible work model

Retirement plan

Job summary

Amgen is seeking a Principal Scientist in Clinical Pharmacology Modeling and Simulation to develop and execute integrated strategies informing dose, regimen selection, study design, and regulatory submissions. You will collaborate with clinical development, pharmacometrics, biostatistics, and regulatory affairs to translate data into decisions.

Responsibilities include leading pharmacology strategies for FIH, DDI, BA/BE, and population PK analyses, and contributing to regulatory submissions and

Qualifications

• Doctorate degree (PhD) or PharmD or MD with relevant experience.
• 5+ years of clinical pharmacology, pharmacometrics, modeling and simulation.
• Strong communication and regulatory submission experience.

Responsibilities

• Lead clinical pharmacology strategy across programs from FIH to post-approval.
• Design, oversee PK/PD, DDI, BA/BE, and other studies.
• Collaborate with cross-functional teams to support regulatory submissions.

Skills

Clinical pharmacology

PK/PD modeling

Quantitative analysis

Regulatory submissions

Education

PhD

PharmD

MD with post-doc

Masters in related field

Bachelor's in Pharmaceutical Sciences

Job description

Amgen is seeking a Principal Scientist in Clinical Pharmacology Modeling and Simulation to develop and execute integrated strategies informing dose, regimen selection, study design, and regulatory submissions. You will collaborate with clinical development, pharmacometrics, biostatistics, and regulatory affairs to translate data into decisions.

Responsibilities include leading pharmacology strategies for FIH, DDI, BA/BE, and population PK analyses, and contributing to regulatory submissions and