Regional Clinical Study Lead — Senior Operations Director

Immunic Therapeutics; United States; Remote; USD 150,000 - 190,000; Full time

Job summary

Immunic Therapeutics seeks a Regional Clinical Study Lead at senior manager/associate director level to provide operational leadership for planning and execution of one or more clinical studies across regions. You will coordinate cross-functional teams, investigative sites, CROs, and vendors to deliver studies safely, on time, within budget, and compliant with protocol and ICH-GCP.

The role combines end-to-end study management, CRO oversight, risk management, and influential leadership in a

Qualifications

• Bachelor's degree or higher in nursing, life sciences, health sciences, or related discipline.

Responsibilities

• Provide operational leadership for planning, start-up, conduct, maintenance, and close-out of global studies or regions.
• Serve as the principal Clinical Operations representative on cross-functional teams and sub-teams.
• Develop, review, and maintain study execution plans, regional strategies, enrollment and oversight plans.
• Contribute to protocol documents, informed consent forms, eCRFs, and study reports.
• Lead country and site feasibility, activation, training, enrollment, and close-out activities.
• Oversee CRO and vendor selection, contracting, performance expectations, governance, issues and invoices.
• Monitor KPIs, quality indicators, milestones, and dashboards; implement corrective actions.
• Identify risks and coordinate resolution with Global Clinical Study Lead and stakeholders.
• Provide inputs to timelines, budgets, accruals, and resource forecasts.
• Coordinate investigator meetings and site communications with stakeholders.
• Ensure sponsor oversight documentation and inspection readiness including eTMF.
• Support audits, inspections, and health-authority interactions with traceable docs.
• Provide coaching and mentoring to junior team members and contribute to standards.
• Act as back-up for Global Clinical Study Lead as assigned.

Job description

Immunic Therapeutics seeks a Regional Clinical Study Lead at senior manager/associate director level to provide operational leadership for planning and execution of one or more clinical studies across regions. You will coordinate cross-functional teams, investigative sites, CROs, and vendors to deliver studies safely, on time, within budget, and compliant with protocol and ICH-GCP.

The role combines end-to-end study management, CRO oversight, risk management, and influential leadership in a