The Head of Study Start-Up is responsible for building and scaling the global SSU function to ensure efficient end-to-end delivery from feasibility to first patient in. This role involves providing strategic direction, managing global teams, and partnering with clients and internal stakeholders to drive operational excellence.
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. With regional hubs in Africa, Latin America, North America, Southeast Asia, and Europe, 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
Head of Study Start-Up will play a critical role in building and evolving the SSU function to meet current operational needs while establishing a scalable, high-performing model for future growth. This is a senior leadership role responsible for the implementation and the subsequent end-to-end delivery, performance, and strategic development of the Study Start-Up (SSU) function across P95 and Julius Clinical. As leader of the Study Start-Up department, this individual will provide strategic direction, operational oversight, and people leadership while acting as a senior partner to sponsors and internal stakeholders.
- Define and scale the global Study Start-Up function to support rapid CRO growth
- Own end-to-end start-up delivery across a growing portfolio, ensuring speed, quality, and consistency from feasibility through first patient in across diverse clients and therapeutic areas
- Foster cross-functional collaboration and active partnership with key stakeholders - including Project Management and Study Operations - throughout the study set-up phase, ensuring alignment on timelines, deliverables, and site readiness ahead of first patient in
- Act as an executive client partner, strengthening strategic relationships and positioning Study Start-Up as a value driver in client delivery and retention
- Leverage analytics, and operational insights to establish KPIs to continuously improve cycle times, productivity, and cost efficiency
- Partner closely with Commercial and Business Unit leadership to shape competitive proposals, differentiated service offerings, and compelling bid defense strategies
- Champion innovation and continuous improvement, standardized processes, and new delivery models to accelerate timelines and enhance quality
- Ensure global compliance and inspection readiness, embedding consistent, high-quality practices aligned with ICH-GCP and regulatory expectations across all regions
- Contribute to broader leadership initiatives and growth strategy
- Bachelor’s degree in life sciences or a related field (advanced degree preferred)
- 10+ yrs in clinical research, significant CRO experience, and hands-on expertise in study start-up
- Experience implementing new departments in a growing organization
- Proven experience leading large, cross-functional and geographically dispersed teams, including mentoring and performance management
- Deep knowledge of clinical trial regulations, guidelines (FDA, EMA, ICH-GCP, GEP, etc.) and start-up best practices
- Stakeholder management and negotiation skills including the ability to manage multiple client portfolios and competing priorities
- Solid financial acumen, including experience with budgeting, forecasting, and resource planning
- Strong collaboration skills, resolving issues in a constructive and team-oriented manner