Senior Director, 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

Senior Director, Clinical Operations

Lead the execution of groundbreaking early-stage clinical programs and drive operational excellence in a high-impact Senior Director, Clinical Operations role. This is a unique opportunity to influence clinical development strategy, oversee global studies, and help advance innovative therapies for patients with unmet medical needs.

About the Opportunity

Our client is an innovative biotechnology organization dedicated to advancing novel therapeutics through early-stage clinical development. The company partners with leading scientific teams to accelerate the development of promising medicines for patients with significant unmet medical needs.

They are seeking a Senior Director, Clinical Operations to provide strategic and operational leadership for the planning and execution of early-stage clinical development programs. Reporting into executive clinical development leadership, this individual will lead clinical operations strategy and execution across clinical pharmacology studies and Phase I/II clinical trials, ensuring high-quality study delivery while helping build scalable operational capabilities within a growing organization.

This is an ideal opportunity for a clinical operations leader who thrives in a fast-paced biotech environment and enjoys balancing strategic leadership with hands-on execution.

Key Responsibilities

Program Leadership

• 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 closely with executive leadership and cross-functional stakeholders to support successful program execution.

Study 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.

Cross-Functional & Vendor Leadership

• 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.

Quality & Process Improvement

• 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.

People Leadership & Innovation

• 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.

Qualifications

Required Experience

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

Technical & Leadership Skills

• Experience with global study feasibility, country and site selection, enrollment forecasting, and operational scenario planning.
• Proven ability to manage multiple studies and competing priorities simultaneously.
• Deep knowledge of ICH-GCP, FDA, EMA, and applicable global regulatory requirements.
• Strong experience with study budgets, forecasting, resource planning, and risk management.
• Exceptional leadership, communication, stakeholder management, and negotiation skills.
• Track record of implementing innovative technologies, systems, or processes that improve clinical trial execution.
• Comfort operating in a lean, fast-paced biotech environment where strategic thinking and hands‑on execution are equally valued.

Why Consider This Opportunity?

• Visible leadership role with significant influence on clinical development strategy.
• Opportunity to oversee multiple innovative early-stage programs.
• High-growth biotechnology environment with strong executive exposure.
• Ability to shape operational excellence and build scalable clinical development capabilities.
• Collaborative culture focused on innovation, agility, and patient impact.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law.

• medical
• dental
• vision coverage
• paid leave

Eligibility may vary based on factors such as location and hire date and is subject to change.