Director Program Operations Leader

Role Responsibilities:
- Lead operational strategy and overall delivery for complex clinical programs.
- Oversee program quality, timelines, budgets, and study team success.
- Provide operational input to Clinical Study Concepts, feasibility, timelines, and cost estimates.
- Review plans during protocol design, study startup, and study conduct.
- Drive decisions, monitor KPIs, and implement risk mitigation strategies.
- Lead vendor selection, CRO oversight, governance activities, and partner meetings.
- Ensure inspection readiness and lead cross-functional support for Regulatory Authority inspections.

Required Qualifications:
- Bachelor’s degree (advanced degree may be considered in lieu of proven experience).
- Minimum 12 years of relevant proven experience.
- Minimum 8 years of experience within clinical operations.
- Knowledge of applicable regulations, ICH/GCP, and SOPs.
- Experience leading complex clinical programs; managing operational strategy, budgets, timelines, and resources.
- Experience forecasting and allocating Clinical Trial Management resources across programs.
- Experience managing CROs, vendors, and external partners.
- Experience representing Clinical Trial Management at review committees and governance meetings.
- Experience leading staff recruitment, performance management, development, coaching, mentoring, training, and compliance activities.
- Ability to communicate effectively with senior management, partners, and cross-functional teams.

Application Instructions:
- Apply now.