Senior Regional Clinical Study Lead

Immunic Therapeutics; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Immunic Therapeutics in Boston, MA seeks a Regional Clinical Study Lead at senior manager/associate director level to provide operational leadership for one or more clinical studies, with direct accountability for regions, countries, and delegated activities.

You will coordinate cross-functional teams, CROs, and vendors to deliver studies safely, on time, within budget, and in compliance with protocol, ICH-GCP, and company procedures.

Qualifications

• Bachelor's degree or higher in nursing, life sciences, health sciences, or a related field.
• 7+ years in pharmaceutical, biotechnology, or CRO environments.
• Experience managing Phase 1–3 studies or regional components end-to-end.
• Experience with outsourced models, CROs, and vendor oversight.

Responsibilities

• Provide operational leadership for planning, start-up, conduct, maintenance, and close-out of global studies or regions.
• Serve as Clinical Operations representative on cross-functional study teams and sub-teams; communicate status and risks.
• Develop, review, and maintain integrated study execution plans and regional strategies.
• Contribute to CRO and vendor selection, contracting, and performance oversight.
• Lead country/site feasibility, activation, enrollment, and close-out activities.
• Monitor study/vendor performance with KPIs and dashboards; implement corrective actions.

Skills

Clinical study management

CRO oversight

Risk management

Cross-functional leadership

Education

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

Tools

eTMF systems

Job description

Immunic Therapeutics in Boston, MA seeks a Regional Clinical Study Lead at senior manager/associate director level to provide operational leadership for one or more clinical studies, with direct accountability for regions, countries, and delegated activities.

You will coordinate cross-functional teams, CROs, and vendors to deliver studies safely, on time, within budget, and in compliance with protocol, ICH-GCP, and company procedures.