• Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance • Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods • Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA • Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs) • Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements

• Data analysis and interpretation • Perform PK analyses independently • Assist with PD analyses • Interpret PK and statistical results and findings independently • Perform QC reviews as assigned • Write and review reports as assigned • Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies • Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects • Other responsibilities • Interact with clients alongside or under direction of a senior scientist, as needed • Prepare internal presentations

• Direct the planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents • Review of AEs/SAEs from clinical trials as needed • Review standard design of tables, figures, and listings for safety data from clinical studies • Participate in development of safety-related data collection forms for clinical studies • Participate in study team meetings as requested or needed • Perform data analysis to evaluate safety signals and write up analysis results • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body • Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans • Develop or update strategy and content for regional risk management plans • Assist GSOs to oversee risk minimization activities including tracking of activities as needed. • Evaluate risk minimization activity • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO • Support activities related to new drug applications and other regulatory filings • Assist GSO in developing a strategy for safety-related regulatory activities • Provide safety contents for filings • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

• Provide scientific and technical support for health-related research, programs, and initiatives • Analyze and interpret scientific data • Support research and program activities • Prepare technical documentation • Collaborate with project teams and stakeholders to meet program objectives