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

Accountabilities:

The Sr. Director will lead the global Regulatory Affairs Study Start-Up (RASSU) function, ensuring effective organizational leadership, strong regulatory governance, financial accountability, and high-quality delivery aligned with sponsor commitments.

• Lead a large, geographically distributed global organization through regional and functional leaders, ensuring appropriate organizational structures, effective spans of control, and consistent execution across regions.
• Define departmental strategy, objectives, performance expectations, and accountability measures aligned with corporate priorities, regulatory requirements, and sponsor commitments.
• Maintain accountability for team delivery, productivity, quality, engagement, retention, and achievement of operational and financial targets.
• Oversee workforce planning, capacity management, organizational design, succession planning, talent development, and performance management.
• Recruit, develop, coach, and retain high-performing leaders and team members while establishing clear expectations for individual and team performance.
• Own departmental budgeting, forecasting, headcount planning, operating expenses, and functional investments.
• Establish and oversee productivity measures, unit tracking, resource utilization, financial reporting, and operational performance indicators.
• Monitor financial and operational results, identify performance variances and emerging risks, and implement corrective actions to improve efficiency, predictability, and profitability.
• Partner with Finance, Commercial, and Operations leadership on pricing assumptions, bid development, scope management, and out-of-scope activities.
• Serve as the functional owner or subject-matter authority for applicable policies, Global Standard Operating Procedures (GSOPs), work instructions, templates, and supporting tools.
• Lead the drafting, review, approval, implementation, training, and periodic revision of controlled documents related to Regulatory Affairs Study Start-Up.
• Ensure departmental procedures and activities comply with applicable regulations, ICH-GCP requirements, local requirements, and internal quality standards.
• Oversee the timely resolution of audit and inspection findings, corrective and preventive actions, quality events, and identified process gaps.
• Define and monitor departmental key performance indicators, quality measures, cycle times, productivity metrics, and financial indicators; analyze trends and implement targeted improvement plans.
• Drive global process harmonization, technology adoption, automation, and continuous improvement to enhance quality, operational efficiency, scalability, and the sponsor experience.
• Represent the organization in sponsor engagements, governance forums, business development activities, Clinical Operations presentations, and bid proposal reviews.

Requirements:

The ideal candidate will bring extensive clinical research experience, a proven record of leading large global teams, and strong expertise in regulatory affairs and study start-up operations. They will combine strategic leadership with financial and operational management capabilities, while building effective relationships across commercial, operational, and functional teams.

• At least 15 years of experience in a contract research organization (CRO), pharmaceutical company, biotechnology company, or related clinical research environment, 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 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.
• Proven experience managing departmental budgets, forecasts, productivity or unit 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.
• Strong understanding of regulatory compliance, clinical research operations, study start-up processes, and applicable industry requirements.
• Demonstrated ability to establish clear performance expectations, develop leadership talent, manage succession planning, and promote engagement and retention across global teams.
• Strong financial and analytical capabilities, including the ability to interpret performance trends, identify risks, and implement corrective measures.
• Excellent communication, stakeholder management, and influencing skills, with the ability to collaborate effectively across regions, functions, and seniority levels.
• Ability to balance strategic priorities with operational execution while maintaining high standards of quality, compliance, and sponsor service.

Benefits:

• Career development opportunities through structured mentoring programs and leadership courses.
• Tuition reimbursement and access to a dedicated training department.
• Medical, dental, and vision benefits.
• Generous vacation and paid time off packages.
• Hybrid work opportunities, where applicable.
• Paid parental leave.
• Work-life balance support and family-oriented benefits.
• Opportunities to contribute to clinical research and the development of treatments for chronically and critically ill patients.
• Opportunities to collaborate with international teams across a global organization.
• Participation in initiatives that support communities and social impact.