Director, Global Clinical Operations – Oncology Trials (Hybrid/Remote)

Fortvita Biologics; United States; Hybrid; USD 180,000 - 230,000; Full time

Job summary

Fortvita Biologics, a San Francisco Bay Area biopharma, seeks a Director of Clinical Operations to drive global Phase I–III trials and vendor oversight in a lean, agile environment.

The ideal candidate has 10+ years in Clinical Operations, oncology experience, and a track record of managing CROs and cross-functional teams to ensure quality, timelines, and regulatory compliance across multiple programs.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 10+ years of Clinical Operations experience in biotech/pharma.
• Experience managing global trials across multiple phases (I–III).
• Must have oncology experience and strong FDA/EMA/ICH-GCP knowledge.

Responsibilities

• Lead and oversee the operational execution of Phase I–III global clinical trials.
• Ensure studies comply with ICH/GCP and regulatory requirements.
• Drive feasibility, site selection, enrollment planning, and vendor onboarding.
• Monitor timelines, budgets, risks, and deliverables for successful execution.
• Oversee study closeout activities and inspection readiness.
• Manage CROs and vendors with governance and performance metrics.
• Provide operational input into study protocols and timelines.
• Mentor Clinical Trial Managers and develop internal capabilities.
• Support SOP/story creation and scalable systems for KPIs.

Skills

Leadership

Project management

Stakeholder management

Communication

Independent working

Education

Bachelor's degree in life sciences or related field

Advanced degree (MS, MBA, PhD) preferred

Job description

Fortvita Biologics, a San Francisco Bay Area biopharma, seeks a Director of Clinical Operations to drive global Phase I–III trials and vendor oversight in a lean, agile environment.

The ideal candidate has 10+ years in Clinical Operations, oncology experience, and a track record of managing CROs and cross-functional teams to ensure quality, timelines, and regulatory compliance across multiple programs.