Global Lead, Early-Stage Clinical Operations

Real; Oakland (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Specialist Staffing Group is seeking a Senior Director, Clinical Operations to lead execution of early-stage clinical programs and to drive operational excellence in a fast-paced biotech environment. You will shape development strategy, oversee global studies, and build scalable operational capabilities.

Reporting to executive leadership, you will guide program leadership, study execution, and vendor management across Phase I/II trials, ensuring on-time delivery within budgets and in compliance

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 10+ years of progressive clinical operations experience in biotechnology, pharmaceutical, or CRO environments.
• Experience leading the operational execution of First-in-Human (FIH) studies, SAD/MAD studies, PK/PD studies, drug-drug interaction studies, food effect studies, and Phase I/II trials.
• Experience managing global and multicenter studies with CRO/vendor oversight, governance, budgeting, and performance monitoring.
• Strong understanding of early clinical development strategy and execution.

Responsibilities

• Lead clinical operations for multiple early development programs, including clinical pharmacology and Phase I/II studies.
• Develop operational strategies aligned with program objectives, including scenario planning related to timelines, budgets, enrollment, and risk mitigation.
• Partner with executive leadership and cross-functional stakeholders to support successful program execution.
• Lead studies from protocol development through closeout.
• Drive global operational strategy, feasibility assessments, enrollment planning, and risk management.
• Ensure studies are executed on time, within budget, and in accordance with quality expectations.
• Lead cross-functional study teams and oversee CRO and vendor relationships, including selection, contracting, governance, and performance management.
• Manage study timelines, budgets, forecasts, resources, and vendor oversight activities.
• Ensure compliance with ICH-GCP and applicable global regulatory requirements.
• Maintain inspection readiness and support quality-focused operational execution.
• Drive process improvements, SOP development, and implementation of operational best practices.
• Mentor and develop clinical operations professionals through direct and matrix leadership.
• Champion innovative approaches to clinical trial execution, including decentralized trial models, digital technologies, and data-driven operational strategies.

Skills

Global study leadership

Budgeting & forecasting

Vendor governance

ICH-GCP knowledge

Stakeholder management

Decentralized trials

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Specialist Staffing Group is seeking a Senior Director, Clinical Operations to lead execution of early-stage clinical programs and to drive operational excellence in a fast-paced biotech environment. You will shape development strategy, oversee global studies, and build scalable operational capabilities.

Reporting to executive leadership, you will guide program leadership, study execution, and vendor management across Phase I/II trials, ensuring on-time delivery within budgets and in compliance