Senior Manager - Clinical Pharmacology Modeling & Simulation

• Manage and train direct reports performing formal PK/PD data analysis, report writing, and quality control of clinical studies
• Review analyses and outputs (ie, tables, figures, listings, and reports) of direct reports performing PK/PD data analyses on clinical studies to ensure accuracy and consistency in accordance with standard processes
• Execution of formal PK/PD data analysis and report writing for clinical studies with a strong emphasis on quality and meeting timelines
• Work closely with CPMS and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally
• Contribute to Amgen’s multimodality development portfolio by conducting formal clinical pharmacology data analyses, summarizing pharmacokinetic/pharmacodynamic (PK/PD) data and results in clinical study report documents, performing quality control, reviewing PK/PD datasets, adhering to applicable regulatory guidance (ie, good clinical practices [GCP]), and providing oversight of clinical pharmacology data analysts performing similar tasks
• Possess good written and oral communication skills, the ability to work well in teams, will demonstrate technical aptitude and a strong work ethic
• Responsible for review and compliance with all applicable SOPs, business practices and company policies

• Master’s degree and 12 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
• OR Bachelor’s degree and 15 years of relevant experience in clinical pharmacology data analysis with an emphasis on non-compartmental analysis
• Following skills are required: experience in people management and career development
• good understanding of clinical pharmacology and pharmacokinetic/pharmacodynamic concepts
• experience in conducting non-compartmental analysis
• experience working with clinical pharmacology datasets and report writing
• experience in working with Phoenix analysis software and with standardized SAS (ADaM) datasets
• Familiar with the drug development process, regulatory guidelines (including Good Clinical Practices), analysis methodology, and clinical pharmacology studies
• Skilled in using Microsoft Office software (ie, Word, Excel, PowerPoint)
• Able to work under tight deadlines
• Strong analytical, writing, communication, organization, and teamwork skills

Bachelor’s or Master’s degree in Pharmacy or related fields such as biology, chemistry, or biochemistry.