Director Project Management - Rare Disease & Pediatrics

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director Project Management - Rare Disease & Pediatrics based in Germany. This senior clinical operations role provides strategic and operational leadership for complex clinical studies and programs across rare disease and pediatric populations. You will serve as a primary client partner, coordinating multidisciplinary teams, vendors, and external partners to deliver studies successfully. The role combines project delivery, risk management, quality oversight, stakeholder leadership, and talent development. You will guide teams through complex challenges while ensuring projects remain aligned with timelines, budgets, regulatory expectations, and quality standards. The position also offers opportunities to strengthen strategic client relationships, contribute to business development, and support portfolio growth. As a people leader, you will help develop high-performing project management talent and build organizational capability for future programs. This is an influential role for an experienced clinical research professional who thrives in complex, collaborative, and high-stakes environments.

Act as the primary client contact for complex clinical studies and programs, managing operational delivery across multiple vendors, sub-CROs, and project teams. Develop and execute strategies to identify, mitigate, and manage operational risks while improving project execution and organizational effectiveness. Lead project teams through the design, implementation, tracking, and maintenance of project plans in accordance with professional standards, SOPs, contracted timelines, and budgets. Oversee the resolution of escalated project issues and provide sound direction in complex or ambiguous situations. Ensure Trial Master Files (TMFs), including TMF plans and indexes, remain audit-ready and are delivered according to agreed timelines when included in the client scope. Lead quality control and risk assurance activities to meet regulatory, internal, and client requirements. Build strong client relationships through proactive communication, collaboration, and consistent delivery, including strategic relationship management when assigned. Develop and maintain strategic client documentation, including charters, Master Service Agreement inputs, rate card contributions, operational plans, and quality plans. Identify and implement process improvements to address delivery variance and strengthen operational performance. Design delivery strategies for large-scale bid defenses and contribute to other business development activities. Provide line management and talent development for project management staff, including attracting, selecting, onboarding, developing, and retaining high-performing professionals. Strengthen talent pipelines and succession planning while providing ongoing mentoring and coaching to experienced team members. Contribute to strategic planning, continuous improvement, portfolio growth, and other organizational priorities as required. Requirements: University or college degree in life sciences or a related discipline; a Master's degree is preferred. At least 9 years of relevant clinical research experience within a pharmaceutical company, CRO, or comparable environment, including at least 6 years with full project management responsibility. At least 4 years of direct or indirect supervisory or people-management experience. Extensive knowledge of the clinical development lifecycle and ICH Good Clinical Practice (GCP) guidelines. Demonstrated expertise managing complex clinical programs involving multiple stakeholders, vendors, and external partners. Strong organizational and time-management skills, with the ability to manage competing priorities and complex delivery requirements. Excellent judgment and decision-making skills, particularly when managing high-stakes or ambiguous situations. Exceptional presentation and communication skills, with the ability to engage internal stakeholders, clients, and executive leadership. Fluent written and spoken English. Demonstrated ability to build trusted relationships with senior stakeholders and contribute to strategic business objectives. Experience in rare disease clinical research is strongly preferred, particularly experience with neonatal and infant pediatric studies. PMP certification or clinical research certification is preferred. Equivalent combinations of relevant education and professional experience may be considered. Benefits: Base salary range of €74,600–€112,860 gross per year for the Italian market, with the applicable range varying according to country of residence and working arrangement. Final compensation determined according to experience, qualifications, scope of responsibilities, internal job classification, and applicable local requirements. Potential eligibility for additional compensation, including bonuses and benefits, according to applicable company policies. Opportunity to lead complex clinical programs in rare diseases and pediatric populations. Senior-level exposure to strategic clients, multidisciplinary teams, and international clinical research programs. Opportunities to develop and mentor project management professionals and contribute to succession planning. Involvement in strategic business development, bid defense, process improvement, and portfolio growth initiatives. International working environment with opportunities to collaborate across functions, vendors, and client organizations.

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