Director, Program Operations Leader - Early Phase Clinical Trials

Role Summary

The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management 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 SOPs within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, interacting with senior management, external vendors, collaboration partners and clinical study personnel for project and department initiatives. The Dir POL is 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(s) status and issues and proactively communicate 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 of studies; ensure consistency within the program and development of best practices within CTM.
• Oversee clinical study budgets within a program: ensure review, presentation and approval of initial study budget and manage 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 and approaches across clinical study teams within the clinical program(s).
• Drive decision making and integrate all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation.
• Be responsible for direct supervision of CTM staff, including work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.

Qualifications

• Required: A Bachelor’s degree and minimum of 12 years’ in-house sponsor-side industry experience, with 8 years within clinical operations.