Principal Scientist - Clinical Pharmacology Modeling and Simulation

Location: Thousand Oaks, California, United States

Company

Amgen is a biotechnology company developing medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead clinical pharmacology activities for one or more development programs from early clinical development through registration and post-approval work.
• Develop integrated strategies covering PK, PD, exposure-response, dose and regimen selection, drug-drug interactions, special populations, formulation changes, and biopharmaceutics.
• Design and oversee first-in-human, drug-drug interaction, ADME, organ impairment, bioavailability/bioequivalence, pediatric, and other clinical pharmacology studies.
• Guide first-in-human starting-dose and escalation decisions using nonclinical pharmacology, toxicology, PK/PD, biomarkers, and predicted human exposure.
• Plan, interpret, and present noncompartmental, population PK, exposure-response, and other quantitative analyses for development and regulatory decisions.
• Provide clinical pharmacology expertise for protocols, study reports, regulatory documents, health-authority interactions, and product labeling.

Requirements

• PhD, PharmD, or MD with relevant postdoctoral training and 2 years of related experience; or a master’s degree with 5 years; or a bachelor’s degree with 7 years of relevant experience.
• Experience in clinical pharmacology, pharmacometrics, modeling and simulation, or related drug development.
• Experience with population PK, PK/PD, PBPK, and QSP modeling.
• Experience designing, overseeing, and interpreting clinical pharmacology studies, including first-in-human, DDI, food-effect, ADME, special population, BA/BE, or bridging studies.
• Experience contributing to regulatory submissions, health-authority interactions, responses to regulatory questions, and product labeling.
• Strong scientific judgment, leadership through influence, cross-functional collaboration, and written and verbal communication skills.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plans with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.