Director – Study Operations

About

P95 Julius Clinical has become AKEURA, a specialist contract research organization (CRO) helping sponsors advance medicines across their full lifecycle. Our dual expertise in early- through late-phase clinical development and real-world evidence is delivered by hands-on clinicians, scientists, and epidemiologists, drawing on more than 25 years of experience. 
We’re built on the belief that a team of the right people, giving everything they’ve got to the needs of the study, will outperform any other approach. Our team of more than 500 experts spanning five continents has delivered more than 1,000 studies in over 75 countries, including regions where patients are hardest to reach. AKEURA exclusively focuses on three therapeutic areas: neuroscience, infectious diseases and vaccines, and cardiometabolic diseases. Across each, we bring the experience, reach and hands-on expertise to give every promising medicine the study it deserves.

Responsibilities

• Full accountability for the coordination, management and performance of the US Study Operations team across all staff levels and locations
• Ownership of the regional budget, including resource planning, expenditure management and forecasting
• Responsibility for the technical and managerial leadership and organizational development of the regional team
• Provide strategic direction on all operational aspects of study set-up and delivery within the region
• Monitor team performance, workload allocation and capacity; identify and resolve conflicts
• Represent Study Operations regionally in cross-functional forums, client interactions and senior internal governance
• Provide input to study proposals and commercial planning for the region
• Lead performance management, goal setting and development planning across the regional teams
• Evaluate and stimulate the performance and development of all Study Ops staff in the region
• Lead the establishment and continuous improvement of departmental processes; drive adoption across the region and alignment to company standards

The Role

This is a senior operational leadership role with end-to-end accountability for the performance, quality, development and budget of the Study Operations function across North America (CRAs, CTA, Leads, etc). They will set the strategic direction for study set-up and delivery in the region, act as the senior escalation point for complex operational issues, and represent Study Operations in cross-functional forums, client interactions and senior internal governance. This is a role for an experienced clinical ops leader within a CRO environment who is able to shape departmental strategy, inspire other managers, and coach teams through the realities of multinational trial delivery.

Requirements

• 10 years of progressive experience in life sciences, including at least 7 years in clinical operations and people management within a CRO environment
• Extensive experience managing multinational clinical trials
• Demonstrable track record of regional team leadership with budget accountability
• Proven line management of CRAs, CTAs and/or CTLs, including management of managers where regional scale requires it
• Academic degree in biomedical sciences or a related life sciences field
• Excellent knowledge of ICH-GCP guidelines and applicable regulatory requirements
• Strong command of the operational aspects of clinical trial set-up and management
• Extensive experience with the development of clinical protocols, policies and SOPs
• Demonstrated experience of budget planning and expenditure management