Project Director, Early Phase and Translational Research (EPTR)

Accountabilities:

• • Oversee a portfolio or program of clinical studies and provide operational direction to the Project Managers responsible for delivery.
  • Ensure studies are conducted in accordance with therapeutic requirements, client expectations, quality standards, SOPs, GCP, ICH guidelines, and applicable regulatory requirements.
  • Act as a senior point of contact for customers, maintaining strong relationships, communicating program progress, and ensuring expectations and deliverables are consistently managed.
  • Provide oversight of study contracts, budgets, expenses, financial tracking, forecasting, and overall project performance.
  • Monitor timelines, milestones, risks, dependencies, and key performance indicators using appropriate project tracking and analysis tools.
  • Maintain deep therapeutic and client-specific knowledge across the assigned portfolio and apply lessons learned consistently across studies.
  • Lead contingency planning, risk mitigation, and proactive issue resolution to support successful study delivery.
  • Oversee complex multinational and multicenter studies, including coordination of functional services and external vendors.
  • Contribute operational expertise to proposal development, pricing, operational strategy, client presentations, and business development activities.
  • Drive continuous performance improvement, operational efficiencies, innovative delivery approaches, and consistency across the project portfolio.
  • Mentor, coach, and provide leadership support to Project Managers, serving as an operational and therapeutic subject matter expert.
  • Support senior leadership initiatives and contribute to the continued development of project management capabilities.

  Requirements:

  • Bachelor’s degree in a relevant scientific or professional discipline; a Master’s degree is an advantage.
  • PMP or PRINCE2 certification is desirable.
  • At least 15 years of relevant industry experience, including a minimum of 5 years within a Contract Research Organization (CRO) environment.
  • At least 10 years of clinical project management experience covering the complete study lifecycle from start-up through closeout.
  • Demonstrated experience managing functional services, external vendors, budgets, timelines, and operational delivery across complex clinical programs.
  • Experience managing mid-size to large multinational studies spanning multiple regions and ideally more than 10–15 countries.
  • Proven experience leading concurrent multicenter, multinational Phase III clinical trials, including financial tracking, forecasting, and budget management.
  • Substantial experience supervising, mentoring, and coaching Project Managers.
  • Strong business development experience, including proposal development, client presentations, bid defense meetings, and operational strategy.
  • Required therapeutic experience in dermatology or rheumatology.
  • Strong knowledge of Good Clinical Practice (GCP) and applicable regulatory requirements, including relevant FDA and Health Canada regulations and guidelines.
  • Strong understanding of international clinical research operations and regulatory expectations.
  • Excellent leadership, communication, stakeholder management, organization, and problem-solving skills.
  • Hands-on leadership style with the ability to balance strategic oversight with detailed operational involvement.
  • Ability to work effectively in a remote, international, and collaborative environment.
  • Eligibility to work legally in Europe.

  Benefits:

  • Fully home-based position with remote working flexibility across Europe.
  • Flexible work schedule.
  • Ongoing learning and professional development opportunities.
  • Opportunity to work with experienced and highly skilled colleagues in a specialized clinical research environment.
  • Exposure to complex, multinational clinical programs across multiple regions.
  • Significant leadership responsibility and opportunities for career advancement.
  • Collaborative environment centered around innovation, reliability, responsiveness, and teamwork.
  • Opportunity to contribute to operational improvements and innovative clinical research strategies.
  • High-impact role combining therapeutic expertise, project leadership, client engagement, and business development.