About the company
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Project Director, Early Phase and Translational Research (EPTR) based in the United States.
Responsibilities
- Portfolio and Program Leadership: oversee a portfolio of clinical studies or large, global, multicenter trials, ensuring Project Managers deliver projects effectively across varying levels of complexity, scope, and therapeutic focus
- Project Delivery and Oversight: ensure studies progress according to approved timelines, budgets, contractual commitments, quality standards, and client-specific requirements, from start-up through completion
- Client Relationship Management: serve as a senior point of contact for clients, maintain strong working relationships, monitor satisfaction, and communicate project progress, risks, and deliverables clearly
- Regulatory Compliance and Quality Assurance: ensure all projects comply with SOPs, Good Clinical Practice (GCP), ICH guidelines, and relevant federal and local regulatory requirements
- Financial and Contract Management: oversee contractual obligations, study budgets, expenses, financial tracking, and forecasting
- Risk Management and Contingency Planning: monitor project progress using timelines, tracking systems, and analytical tools; identify potential challenges early and implement risk mitigation and contingency strategies
- Therapeutic and Operational Expertise: maintain in-depth knowledge of assigned therapeutic areas and client requirements
- Business Development and Proposal Support: lead or contribute to proposal development, operational strategy, pricing, client presentations, and bid defense meetings
- Operational Excellence and Innovation: drive continuous improvement, operational efficiencies, and innovative project delivery approaches
- People Leadership and Development: provide oversight, coaching, and mentorship to Project Managers
Requirements
- Bachelor's degree in science or a relevant discipline required; master's degree is an asset; PMP or PRINCE2 certification is an advantage
- At least 15 years of experience in the clinical research industry, including a minimum of five years within a Contract Research Organization (CRO)
- At least 10 years of clinical project management experience covering the complete study lifecycle, from start-up to closeout, including oversight of functional services and vendor management
- Demonstrated experience managing complex, multicenter clinical trials, ideally including Phase III multinational studies spanning more than 10–15 countries; experience across North America, South America, Asia-Pacific, the Middle East and North Africa, and Europe is desirable
- Previous experience in dermatology or rheumatology clinical trials is required
- Proven ability to oversee project budgets, financial tracking, forecasting, resource planning, and contractual obligations across multiple studies
- Leadership and mentorship experience