The Director Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence.Director Program Operations Leader - Specialty Medicine, Rare Disease(For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.)In a typical day, you will:Be responsible for the overall success of the clinical study team(s) within a program(s)Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requestedProvide operational insight into feasibility, timeline and cost estimates during clinical program/study developmentOversee clinical study timelines within a clinical program(s)Provide input and operational insight into Clinical Study Concepts (CSC)Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTMOversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriateEnsure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementationAct as point of contact for clinical program and study level escalationReview key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progressProvide proactive creation and implementation of risk mitigation strategiesProvide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challengesDrives the strategy and oversight for vendor selection and management within a clinical program(s)Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterpartsMay require up to 25% travelTo be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations.For US Locations, this position is on-site 4 days per week and 1 day from home.
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