Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience)

CTI Clinical Trial and Consulting Services•Raleigh, NC

1d•Onsite

About The Position

Provides strategic and operational leadership for the global Regulatory Affairs Study Start-Up (RASSU) function, with accountability for organizational performance, delivery quality, financial management, resource capacity, and achievement of corporate and sponsor objectives. Leads a large, geographically dispersed team through regional and functional leaders and establishes clear expectations for performance, productivity, quality, and professional development. Owns departmental budgeting, forecasting, unit and productivity tracking, resource utilization, and financial performance. Provides governance and subject-matter leadership for applicable policies, Global Standard Operating Procedures (GSOPs), work instructions, and supporting processes, ensuring regulatory compliance, operational consistency, inspection readiness, and continuous improvement across the global organization.

Requirements

At least 15 years of CRO, pharmaceutical, biotechnology, or other relevant clinical-research experience, including progressive leadership responsibility for complex global Regulatory Affairs and study start-up activities.
Master’s or doctoral degree in a health-related discipline, or an equivalent combination of education and experience as determined by CTI Management and Human Resources.
Demonstrated experience leading a large, geographically dispersed global organization through regional or functional leaders, with accountability for team performance, capacity, quality, and delivery.
Demonstrated experience owning departmental budgets, forecasts, unit or productivity tracking, resource utilization, and operational and financial performance metrics.
Experience leading global organizational transformation, process harmonization, technology implementation, or automation initiatives
Experience supporting commercial strategy, pricing, bid development, scope management, or sponsor governance within a CRO or related environment.

Responsibilities

Leads a large, geographically dispersed global RASSU organization through regional and functional leaders, ensuring an effective organizational structure, appropriate spans of control, and consistent execution across regions.
Establishes departmental strategy, objectives, performance expectations, and accountability measures aligned with corporate strategy, regulatory requirements, and sponsor commitments.
Maintains overall accountability for team delivery, productivity, quality, engagement, retention, and achievement of operational and financial targets.
Leads workforce planning, capacity management, organizational design, succession planning, talent development, and performance management across the function.
Attracts, develops, coaches, and retains high-performing leaders and team members; establishes clear expectations and holds leaders accountable for team performance and development.
Owns development, management, and ongoing forecasting of the departmental budget, including headcount, operating expenses, and functional investments.
Establishes and oversees unit tracking, productivity measures, resource utilization, forecasting, and financial reporting to ensure alignment with corporate objectives.
Monitors financial and operational performance, identifies variances and emerging risks, and implements corrective actions to improve efficiency, predictability, and profitability.
Partners with Finance, Commercial, and Operational leadership to support pricing assumptions, bid development, scope management, and out-of-scope activities.
Serves as the functional owner or subject-matter authority for applicable GSOPs, policies, work instructions, templates, and supporting tools.
Leads the drafting, review, editing, approval, implementation, training, and periodic revision of RASSU-related controlled documents.
Ensures procedures and activities remain compliant with applicable regulations, ICH-GCP requirements, local requirements, and company quality standards.
Maintains accountability for timely resolution of audit and inspection findings, corrective and preventive actions, quality events, and identified process gaps.
Defines and monitors departmental key performance indicators, quality measures, cycle times, productivity indicators, and financial metrics; reviews trends and implements targeted improvement plans when expectations are not met.
Drives global process harmonization, technology adoption, automation, and continuous improvement to enhance quality, efficiency, scalability, and the sponsor experience.
Represents CTI in sponsor engagements, governance forums, business-development activities, Clinical Operations presentations, and review of bid proposals.