Associate Director Clinical Operations

Barrington James; United States; Remote; USD 180,000 - 230,000; Full time

Job summary

Barrington James is seeking an Associate Director, Clinical Operations (Oncology) to lead end-to-end global Phase 2/3 oncology studies, from start-up to close-out, in a remote-capable role.

You will manage CROs, budgets, timelines, and risk, mentor trial managers, ensure ICH GCP and FDA compliance, and partner across Clinical Development, Regulatory, Data Management, Biostatistics and Drug Supply. This is a hands-on leadership role for a fast-scaling biopharma with strong oncology programs.

Qualifications

• 8+ years of clinical operations experience in biotech, pharma or CRO.
• Strong oncology experience; hematology a plus.
• Proven track record delivering global Phase 2/3 studies, ideally registrational.

Responsibilities

• Lead planning and execution of global Phase 2/3 oncology trials, ensuring delivery to timeline, budget and quality.
• Select, manage and oversee CROs and vendors, holding partners accountable to performance metrics.
• Build and manage study budgets, timelines and risk mitigation plans.
• Drive site selection, start-up and enrolment strategy across the US and global regions.
• Partner with Clinical Development, Regulatory, Data Management, Biostatistics and Drug Supply.
• Ensure inspection readiness and compliance with ICH GCP and FDA requirements.
• Line manage and mentor Clinical Trial Managers and study team members.

Skills

Oncology operations

Clinical trial leadership

Vendor/CRO management

Budget management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Associate Director, Clinical Operations (Oncology)

Location: Remote | EAST COAST US

About the company

Our client is a global biopharmaceutical company with approved oncology therapies on the market and a deep late-stage pipeline across hematologic malignancies and solid tumours. With multiple global Phase 3 registrational studies underway, they are expanding their US Clinical Operations team and looking for an experienced leader to drive study delivery.

The role

Reporting into senior Clinical Operations leadership, you will own the end-to-end execution of global oncology studies, from start-up through close-out. This is a hands-on leadership role with real ownership, working closely with global cross-functional teams as programs move toward regulatory filing.

Key responsibilities

• Lead the planning and execution of global Phase 2/3 oncology trials, ensuring delivery to timeline, budget and quality
• Select, manage and oversee CROs and vendors, holding partners accountable to performance metrics
• Build and manage study budgets, timelines and risk mitigation plans
• Drive site selection, start-up and enrolment strategy across the US and global regions
• Partner with Clinical Development, Regulatory, Data Management, Biostatistics and Drug Supply
• Ensure inspection readiness and compliance with ICH GCP and FDA requirements
• Line manage and mentor Clinical Trial Managers and study team members

About you

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• 8+ years of clinical operations experience within biotech, pharma or CRO, including study management leadership
• Strong oncology experience, with hematology a plus
• Proven track record delivering global Phase 2/3 studies, ideally registrational
• Deep experience managing CROs and vendors in an outsourced model
• Comfortable in a fast-paced, scaling environment where you will help shape processes