Director Project Management - Rare Disease & Pediatrics
Quick Summary
This position is listed on behalf of a partner company, who manages all applications and next steps.
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
~1 min read- 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.
What We Offer
~2 min readLocation & Eligibility
Listing Details
- Posted
- September 21, 2026
- First seen
- September 27, 2026
- Last seen
- September 27, 2026
Posting Health
- Days active
- 0
- Repost count
- 0
- Trust Level
- 46%
- Scored at
- September 27, 2026
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