Director Project Management, Rare Disease and Pediatrics

About the role

Serve as the main client lead for complex clinical studies or programs, steering operational delivery across vendors and teams while managing risk and developing project management staff. The role is remote within the US.

What you will do

• Act as primary client contact for assigned studies or programs, working independently on complex strategy with multiple vendors and sub-CROs
• Set risk management and control strategies and improve operational execution
• Resolve escalated project issues and oversee line management and development of project managers
• Lead teams through design, implementation, tracking and upkeep of project plans within agreed timelines and budget
• Ensure trial master files meet audit readiness and delivery timelines when contracted, and drive quality control and risk assurance
• Support business development, including large bid defence strategy, and help grow client portfolios

What they look for

• Fluent written and verbal English with deep knowledge of clinical development and ICH GCP
• Strong organisational and time management abilities and sound judgment in ambiguous, high-stakes situations
• Excellent presentation skills for internal and partner executive audiences
• University degree in life sciences, with a master's preferred
• At least nine years of relevant clinical research experience in pharma or a CRO, including six or more years of full project management resp
• Four or more years of direct or indirect supervisory experience

Nice to have

• Rare disease experience
• Neonatal and infant pediatric study experience