Director, Program Operations Leader - Early Phase Clinical Trials

Role Summary

Director, Program Operations Leader (POL) responsible for leadership and strategic management of one or more complex programs in Clinical Trial Management (CTM). Oversees 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, and SOPs within assigned program(s). Member of the Clinical Trial Management extended leadership team; interacts with senior management, external vendors, collaboration partners and study personnel. Responsible for line management of CTM staff, including recruitment, development, coaching, mentoring, and performance management.

Responsibilities

• Be responsible for the overall success of the clinical study team(s) within a program(s)
• Maintain an overview of clinical program 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)
• Review plans and provide clinical operations expertise during protocol design, feasibility, study start up and conduct phases; 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 accountability for ensuring consistency of process across clinical study teams within the program(s)
• Drive decision making and integrate all operational considerations for studies within a clinical program to ensure goals are attainable prior to implementation
• Direct supervision of CTM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

Qualifications

• Required: Bachelor‚Äôs degree and minimum of 12 years relevant in-house sponsor-side industry experience, with 8 years within clinical operations

Skills

• Operational leadership in clinical trial management
• Budget management and financial oversight for clinical programs
• Protocol design support and study start-up experience
• Staff leadership, development, and performance management
• Stakeholder communication and cross-functional collaboration

Education

• Bachelor‚Äôs degree (field not specified)

Additional Requirements

• Location details: US on-site 4 days/week with 1 day from home; USUxbridge/Dublin on-site 3 days/week with 2 days from home; fully remote role not possible