Director Program Operations Leader

Director Program Operations Leader

The Director Program Operations Leader 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 Director Program Operations Leader 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 Director Program Operations Leader 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 Program Operations Leader is expected to operate with autonomy and high-degree of independence.

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 requested
• Provide operational insight into feasibility, timeline and cost estimates during clinical program / study development
• Oversee 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 CTM
• Oversee 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 appropriate
• Ensure 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 implementation
• Act as point of contact for clinical program and study level escalation
• Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
• Provide proactive creation and implementation of risk mitigation strategies
• Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
• Drives 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 counterparts
• May require up to 25% travel

To 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.

$205,000.00 - $341,600.00