Director, Study Operations

P95 Julius Clinical is a leading global, full-service Clinical Research Organization (CRO) delivering integrated clinical development and real-world evidence solutions across five continents. Formed through the strategic merger of P95 and Julius Clinical, the organization combines P95's leadership in infectious diseases, vaccines, and real-world evidence with Julius Clinical's expertise in central nervous system, cardio-metabolic, renal, and rare diseases, creating a unique mid-sized CRO with scale, agility and scientific depth.

We operate with a team of 500 professionals and a track record that includes more than 1000 clinical trials conducted in over 50 countries. We offer comprehensive CRO capabilities supporting both full-service and modular approaches across the entire development lifecycle and post-marketing phases for pharmaceutical, biotech, and public health partners.

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 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.

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