Global Clinical Operations Lead - Associate Director

Oblenio Bio, Inc.; Lexington (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Oblenio Bio, a clinical-stage biotech focused on T-cell engagers, seeks an Associate Director, Global Clinical Operations to lead global trial execution from start-up to close-out. You will manage CROs, vendors, timelines, budgets, and risk plans while collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes hands-on, fast-paced execution in a lean environment, with on-site work in Lexington, MA 2–3 days per week and opportunities for remote

Qualifications

• 8+ years in clinical operations with global trials.
• Experience managing CROs, vendors, budgets, and timelines.
• Strong knowledge of ICH-GCP and regulatory requirements including GDPR.
• Experience in early-stage development, immunology or biotech is a plus.

Responsibilities

• Serve as global Clinical Operations lead for assigned trials and workstreams.
• Develop and track study plans, timelines, budgets, enrollment forecasts, risk registers, and KPIs.
• Oversee CROs and clinical vendors, including contracting and performance metrics.
• Coordinate site identification, feasibility, activation, enrollment, monitoring, and closeout.
• Partner with Clinical Development, Regulatory, Data Management, CMC, Quality, and Translational Sciences.
• Contribute input to protocol development and study design with operational considerations.
• Ensure activities comply with ICH-GCP, GDPR, and company procedures; support inspection readiness.
• Lead or facilitate study team and vendor meetings, provide status reporting and risk escalation.

Skills

CRO management

Vendor oversight

Study timelines

Risk management

Global operations

Education

Bachelor's degree in science/healthcare

Advanced degree preferred

Job description

Oblenio Bio, a clinical-stage biotech focused on T-cell engagers, seeks an Associate Director, Global Clinical Operations to lead global trial execution from start-up to close-out. You will manage CROs, vendors, timelines, budgets, and risk plans while collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes hands-on, fast-paced execution in a lean environment, with on-site work in Lexington, MA 2–3 days per week and opportunities for remote