Director, Study Operations

About

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.

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.

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

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