Clinical Study Delivery Lead, Global Clinical Operations, Oncology Therapy Area, R&D, Orion Cor

Clinical Study Delivery Lead, Global Clinical Operations, Oncology Therapy Area, R&D, Orion Corporation

The Clinical Study Delivery Lead provides global leadership for the planning, set up, execution, oversight, and delivery of complex oncology clinical trials from First in Human (FIH) through late phase Ph2/3 registration studies and submission. The role is responsible for driving study execution, ensuring high quality data, maintaining compliance with GCP/ICH, and managing cross functional and cross regional teams to achieve program goals within scope, budget, timelines, and quality standards.

This role brings strong expertise in oncology clinical development studies, in immuno‑oncology, biologics, targeted therapies, and solid tumor indications.

• Lead the end to end execution of global Phase I–III oncology studies, including FIH and registration enabling trials, from startup through closeout, to ensure the study is delivered within timelines, budget and with high quality.
• Provide hands‑on project leadership in a global, cross‑functional setting, including study timelines projection, protocol development support, site selection/activation, vendor management, timeline/budget oversight, risk/issue resolution, and CRO performance management.
• Lead the study team and drive study execution through team collaboration, ensuring alignment across internal teams and external partners, and act as a self‑starter in a fast‑paced, resource‑constrained environment.
• Plan, drive and oversee study startup, site activation, enrollment strategy, patient retention, data quality oversight, database readiness, study reporting and CSR delivery aligned with regulatory strategy submission plans.
• Ensure rigorous vendor oversight, particularly CRO performance (monitoring, data management, labs, imaging, ePRO, etc.). Proactively identify operational risks and implement robust mitigation plans. Escalate critical issues and propose solutions to senior leadership.
• Plan and manage study timelines, project site activation, recruitment and readout timelines, including building various scenarios depending on data‑driven study outcome assumptions and other requirements.
• Manage clinical trial budgets, forecasting, accruals, and change orders.
• Ensure adherence to ICH GCP, local/global regulations, SOPs, and audit readiness, including responding to audits/inspections, and coordinate CAPA implementation, as needed.
• Partner closely with internal and external stakeholders to deliver integrated milestones.
• Chair global study team meetings, drive team collaboration and ensure clear decision making and documentation.
• Build strong relationships with investigators, global KOLs, and academic partners as required.
• Lead patient engagement strategies throughout clinical trial design, startup, and execution to ensure patient‑centric study planning, enhance recruitment and retention, and incorporate patient insights into operational decision making.

This role is based in Cambridge (MA), US and reports to VP, Global Clinical Operations.

• Master's degree in a scientific discipline preferred (advanced degree favored); equivalent extensive experience considered (e.g., from nursing/monitoring background progressing to PM).
• 10+ years of clinical operations experience, with 5+ years leading global oncology studies.
• Proven leadership of early phase oncology trials, including FIH, dose escalation/expansion, safety monitoring, and DMC interactions.
• Experience with late phase, global registration directed trials, including operational planning for NDA/BLA/MAA submissions.
• Experience in immuno‑oncology, biologics and targeted therapies in solid tumor indications.
• Demonstrated ability to manage global CROs, complex budgets, and multi‑vendor landscapes.
• Strong understanding of oncology drug development, adaptive design, biomarkers, imaging, safety reporting, and protocol complexities.
• Expertise in ICH GCP, global regulatory requirements, and inspection readiness.
• Strong team player, and team‑driver mindset with excellent communication, negotiation, conflict resolution, and stakeholder management skills.
• Hands‑on, pragmatic, solution‑oriented approach, analytical skills, and ability to anticipate/resolve issues proactively.
• Ability to travel internationally as needed.

• Experience in small biotech and/or fast‑paced growth environments.

Please send your application with the latest CV and cover letter by 26th of July, 2026.

The expected annual salary range for this position is USD 140,000–230,000 per year. Final compensation will depend on skills, experience, and job‑related qualifications.