Director Project Management - Rare Disease & Pediatrics

Accountabilities:

• 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.

• 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.

This listing is from Lever. View original listing ↗