Global Clinical Ops Lead – Hybrid & Equity Eligible

Phathom Pharmaceuticals; Buffalo Grove (IL); On-site; USD 185,000 - 220,000; Full time

Benefits offered by this job

Competitive benefits

401(k) match

Employee stock purchase plan

Paid parental leave

Hybrid/ Flexible work

HSA

Job summary

Phathom Pharmaceuticals seeks an experienced Associate Director, Clinical Operations to lead global clinical development programs and ensure timely, compliant study execution. You will oversee CRO/vendor management, budgeting, cross-functional collaboration, and regulatory readiness, while guiding a growing Clinical Operations team in a fast-paced biotechnology environment.

The role requires strong ICH-GCP knowledge and oversight of complex multi-indication studies, with partner engagement at

Qualifications

• Bachelor's degree required and 8+ years of clinical/operations experience.
• Experience managing complex, global clinical trials across multiple therapeutic areas.
• Strong understanding of ICH-GCP, FDA regulations, EU trials, and global compliance.
• Experience with CROs, vendors, investigators and external partners.
• Regulatory inspections and audit readiness experience.
• Excellent project management, organizational and prioritization skills.
• Strong written, verbal and presentation communication abilities.

Responsibilities

• Lead and oversee execution of multiple clinical studies within assigned development programs.
• Drive operational strategy and execution to support development plans and program objectives.
• Manage complex studies with multiple indications, interim analyses, DSMBs, and global vendors.
• Ensure studies are delivered on time, within budget, and compliant with ICH-GCP and regulations.
• Oversee scope, timelines, milestones and risk mitigation plans.
• Oversee CROs and external vendors; budget discussions and performance management.
• Partner with CROs to develop study management, enrollment, monitoring, and risk plans.
• Develop and manage program budgets and forecasts; liaison with Finance for enrollment and spend.
• Provide updates to senior leadership on status, risks, timelines and financials.
• Support regulatory interactions and due diligence for new compounds and partnerships.
• Mentor Clinical Operations staff and contribute to training and process improvements.

Skills

Leadership

Vendor management

Cross-functional collaboration

Project management

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline

Job description

Phathom Pharmaceuticals seeks an experienced Associate Director, Clinical Operations to lead global clinical development programs and ensure timely, compliant study execution. You will oversee CRO/vendor management, budgeting, cross-functional collaboration, and regulatory readiness, while guiding a growing Clinical Operations team in a fast-paced biotechnology environment.

The role requires strong ICH-GCP knowledge and oversight of complex multi-indication studies, with partner engagement at