Amgen Sr. Associate Strategic Planning & Operations in Thousand Oaks, California
Amgen is seeking a Sr. Associate of Strategic Planning & Operations at its headquarters in Thousand Oaks, CA to join the Center for Observational Research (CfOR) organization. This individual will report to the Strategic Planning and Operations Manager.
This role will support the CfOR organization by managing study contracts, financials, reports and study timelines, and by working with the Amgen Responsible Employees (RAEs) within CfOR to manage, track and analyze key operational data. The Sr. Associate is responsible to stay informed of best practices and provide innovative, impactful ideas to optimize processes to support the organization's growth strategies.
Amgen has established the Center for Observational Research (CfOR) which consolidates Epidemiology, Pharmacovigilance and Health Economics Observational Research into one organization. CfOR will design, conduct, analyze, interpret, and publish observational research that informs the safety, efficacy, effectiveness, and economic value of Amgen products.
Observational research (OR) is an increasingly important component in drug development and commercialization. This team contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions.
Manage observational study budget, resourcing, key deliverables and contracts for department RAEs.
Lead the development of realistic timelines, from contracting to final study reporting.
Support contracting activities (as appropriate) for the organization
Develop and own processes to track and collaborate with stakeholders to successfully fulfil critical milestones for studies.
Adhering to all Amgen policies, clinical development processes, SOPs and clinical project management processes.
Collaborate with other partners to foster positive interactions and processes between the center and other key partners (e.g., GBDS, GDO, GRAAS, GHE/iHE)
Support inspection readiness activities as requested
Bachelor's degree and 1 year of contracting or study coordination or project management experience
Associate's degree and 3 years of contracting or study coordination or project management experience
High school diploma / GED and 6 years of contracting or study coordination or project management experience
Contract Negotiations experience
Ariba / SAP knowledge
Excel / Word / Powerpoint
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.