Global Director, Regulatory Study Start-Up

CTI Clinical Trial and Consulting Services; Covington (KY); Sur place; USD 180 000 - 230 000; Plein temps

Avantages offerts par ce poste

Hybrid work from home opportunities

Tuition reimbursement

Paid parental leave

Health benefits

Résumé du poste

CTI Clinical Trial and Consulting Services is seeking a senior leader to direct the global Regulatory Affairs Study Start-Up (RASSU) function from its Covington, KY headquarters or Raleigh, NC office.

You will own strategy, budgeting, forecasting, and performance across a large, dispersed team, ensuring regulatory compliance, inspection readiness, and continuous improvement in collaboration with Finance, Commercial, and Operations.

Qualifications

• 15+ years CRO/pharma/biotech with global RA startup leadership experience.
• Master’s or doctoral degree in a health-related discipline.
• Experience leading large, dispersed global organization with accountability for performance.
• Experience owning departmental budgets, forecasts, and performance metrics.
• Experience with global transformation, process harmonization, or automation initiatives.

Responsabilités

• Lead a large, globally dispersed RASSU organization through regional/function leaders.
• Set departmental strategy, objectives, and performance expectations.
• Own budgeting, forecasting, unit tracking, resource utilization, and financial reporting.
• Drive workforce planning, succession planning, and talent development across the function.
• Oversee GSOPs, policies, and controlled documents related to RASSU.

Connaissances

Leadership

Budgeting & Forecasting

Regulatory Affairs

Strategic Planning

Cross-functional collaboration

Formation

Master’s or Doctoral degree in health-related discipline

Description du poste

CTI Clinical Trial and Consulting Services is seeking a senior leader to direct the global Regulatory Affairs Study Start-Up (RASSU) function from its Covington, KY headquarters or Raleigh, NC office.

You will own strategy, budgeting, forecasting, and performance across a large, dispersed team, ensuring regulatory compliance, inspection readiness, and continuous improvement in collaboration with Finance, Commercial, and Operations.