Senior Director, Regulatory Affairs Study Start-Up
New
J
JobgetherClinical research
Based in the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 15 years of experience
Requirements
- At least 15 years of experience in a CRO, pharmaceutical company, biotechnology company, or related clinical research environment.
- 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.
- Experience leading a large, geographically dispersed organization through regional or functional leaders.
- 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.
- Ability to develop leadership talent, manage succession planning, and promote engagement and retention across global teams.
- Strong financial and analytical capabilities, including interpreting performance trends, identifying risks, and implementing corrective measures.
- Communication, stakeholder management, and influencing skills to collaborate across regions, functions, and seniority levels.
Responsibilities
- Lead the global Regulatory Affairs Study Start-Up function through regional and functional leaders.
- Define departmental strategy, objectives, performance expectations, and accountability measures.
- Oversee team delivery, productivity, quality, engagement, retention, and operational and financial targets.
- Manage workforce planning, capacity, organizational design, succession planning, talent development, and performance management.
- Own departmental budgeting, forecasting, headcount planning, operating expenses, and functional investments.
- Establish productivity measures, resource utilization, financial reporting, and operational performance indicators.
- Partner with Finance, Commercial, and Operations leadership on pricing assumptions, bid development, scope management, and out-of-scope activities.
- Oversee controlled documents and ensure procedures comply with regulations, ICH-GCP requirements, local requirements, and internal quality standards.
- Drive global process harmonization, technology adoption, automation, and continuous improvement.
- Represent the organization in sponsor engagements, governance forums, business development, Clinical Operations presentations, and bid proposal reviews.
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