Senior Phase I Study Lead – Immunology

OpenKrill; United States; Hybrid; USD 146,000 - 218,000; Full time

Job summary

Numab Therapeutics AG in Switzerland/UK is seeking a Senior Study Manager (Immunology) to lead Phase I studies, manage CROs, and drive site activation and recruitment. You will oversee data systems, safety data readiness, and protocol amendments in a lean biotech setting.

The role emphasizes early‑phase study leadership, cross‑functional collaboration, and direct ownership of study plans, timelines, and budgets. International collaboration with sites and vendors is expected.

Qualifications

• Substantial clinical operations experience in early phase trials.
• Experience leading CROs and coordinating multi-site studies.
• Strong understanding of dose escalation and safety reviews.
• Familiarity with trial systems and data quality controls.

Responsibilities

• Lead operational delivery of Phase I studies from start-up to close-out.
• Act as day-to-day operational counterpart to CRO; set expectations and track commitments.
• Develop integrated study plans, milestones, and risk logs to accelerate modifications.
• Review CRO deliverables and ensure actions are completed.
• Coordinate readiness for dose-escalation and safety review meetings.
• Support study governance with concise updates for leadership.
• Forecast study scope, timelines, budgets and vendor performance.
• Lead protocol amendments and study expansions with internal and CRO teams.
• Maintain site readiness, activation, and recruitment progress.
• Ensure data systems readiness and data integrity across sites.

Skills

Early-phase study leadership

CRO management

Site activation & recruitment

Dose-escalation studies

Budget & vendor management

ICH/GCP knowledge

Education

Advanced degree in life sciences

Job description

Numab Therapeutics AG in Switzerland/UK is seeking a Senior Study Manager (Immunology) to lead Phase I studies, manage CROs, and drive site activation and recruitment. You will oversee data systems, safety data readiness, and protocol amendments in a lean biotech setting.

The role emphasizes early‑phase study leadership, cross‑functional collaboration, and direct ownership of study plans, timelines, and budgets. International collaboration with sites and vendors is expected.