.Pfizer Clinical Study Team Lead (Director) in Bothell, United States JOB SUMMARY .Clinical Development expert focused on the execution of clinical studies and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas.Single point of accountability for input into study design to ensure feasibility of execution, planning and delivery of clinical studies on time, within the approved budget and with quality.Experienced project manager and matrix leader accountable for leading the study team delivery of multiple complex global studies and/or programs.Responsible for developing and overseeing clinical study timelines and budgets. - Partners and collaborates with functional line leadership to ensure optimal resourcing of the study team.Responsible for proactive risk management and inspection readiness for their clinical study(ies). Your responsibilities may also include:Ensures comprehensive operational input to submission plan.Lead the delivery of Module 2/5 deliverables to support market authorizations including leading cross functional Module 2/5 submission sub- teams with accountability for overall operational strategy.Develops and leads execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, and rapid response.Manages other submissions activities as necessary.Accountable for managing overall submission CD&O sub-team timelines, budgets, and quality targets.Accountable for building, forecasting, and managing the CD&O submission budget.Oversees operational metrics across submission sub-teams and manages trends and escalations.Work at the program level; at the program level the CSTL is accountable for developing the execution strategy and managing the timelines, budgets, and quality across multiple studies in the program.DESCRIPTION:Provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution.Leads and coordinates the execution of a clinical studies from Sourcing Strategy and Study Specification development for Requests for Proposals, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data.Provides input to and supports compilation of sections to Clinical Study Reports and provide program-level insights. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones.Monitors CRO and vendor contracts for out-of-scope activities and budget spend/invoices for assigned vendors.Provides centralized Pfizer Oversight to fully outsourced studies.A member of the GPD due diligence team for business development opportunities. Partner with GPD leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category
