Project Director, Early Phase and Translational Research (EPTR)

Accountabilities: Portfolio and Program Leadership: Oversee a portfolio of clinical studies or large, global, multicenter trials, ensuring that 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 applicable standard operating procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and relevant federal and local regulatory requirements. Financial and Contract Management: Oversee contractual obligations, study budgets, expenses, financial tracking, and forecasting to support sound financial performance across the assigned portfolio. Risk Management and Contingency Planning: Monitor project progress using timelines, tracking systems, and analytical tools. Identify potential challenges early and implement consistent risk mitigation and contingency strategies. Therapeutic and Operational Expertise: Maintain in-depth knowledge of assigned therapeutic areas and client requirements, applying lessons learned across projects to strengthen delivery and improve outcomes. Business Development and Proposal Support: Lead or contribute to proposal development, operational strategy, pricing, client presentations, and bid defense meetings, leveraging clinical and project management expertise to support business growth. Operational Excellence and Innovation: Drive continuous improvement, operational efficiencies, and innovative project delivery approaches that enhance quality, consistency, and overall performance. People Leadership and Development: Provide oversight, coaching, and mentorship to Project Managers, support their professional growth, and contribute to leadership initiatives within the project management function. Requirements Education: A bachelor's degree in science or a relevant discipline is required. A master's degree is considered an asset. Project Management Professional (PMP) or PRINCE2 certification is also an advantage. Industry Experience: At least 15 years of experience in the clinical research industry, including a minimum of five years working within a Contract Research Organization (CRO). Clinical Project Management: 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. Large-Scale Trial Experience: 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. Therapeutic Expertise: Previous experience in dermatology or rheumatology clinical trials is required . Financial and Operational Management: Proven ability to oversee project budgets, financial tracking, forecasting, resource planning, and contractual obligations across multiple studies. Leadership and Mentoring: Substantial experience supervising, coaching, and mentoring Project Managers, with the ability to build high-performing teams and encourage accountability. Business Development: Demonstrated experience contributing to proposals, pricing strategies, client presentations, and bid defense meetings. Regulatory Knowledge: Strong understanding of Good Clinical Practice (GCP), applicable Health Canada and U.S. Food and Drug Administration (FDA) regulations and guidelines, and relevant international clinical research standards. Strategic Thinking and Problem-Solving: Strong analytical skills, sound judgment, and the ability to anticipate risks, resolve complex operational challenges, and implement effective solutions. Communication and Collaboration: Excellent communication and relationship-building skills, with the ability to work effectively with clients, senior stakeholders, cross-functional teams, and external partners. Adaptability and Continuous Improvement: A proactive, hands-on leadership style and a demonstrated commitment to innovation, operational efficiency, quality, and continuous learning. Benefits Employment Type: Permanent, full-time position. Work Arrangement: Home-based, remote position available to eligible candidates in North America. Flexible Schedule: Flexible working hours to support work-life balance. Professional Development: Ongoing learning opportunities and support for career advancement. Collaborative Environment: Work alongside experienced clinical research professionals in a team that values collaboration, innovation, reliability, and responsiveness. Meaningful Impact: Opportunity to influence clinical trial delivery, contribute to organizational growth, and shape operational strategies across a global portfolio. Accessibility and Inclusion: Accommodations are available upon request throughout the recruitment and selection process. Eligibility: Applicants must be legally authorized to work in North America.