Senior Director, Clinical Operations

Company: Clinical-Stage Cell and Gene Therapy Organization
Location: San Diego, California
Work Arrangement: Hybrid
Employment Type: Permanent

The Opportunity

Brio has partnered with a clinical-stage biopharmaceutical organization advancing differentiated cell and gene therapies to recruit a Senior Director, Clinical Operations.

This leader will oversee global clinical trial execution across innovative therapeutic programs, translating development objectives into practical operating plans while ensuring disciplined management of timelines, budgets, quality, and external partnerships.

Key Responsibilities

• Provide operational leadership for global clinical studies from planning and start-up through database lock and closeout.
• Develop study plans, timelines, budgets, resourcing strategies, and performance metrics.
• Lead and develop Clinical Trial Managers and other Clinical Operations professionals.
• Oversee CROs, functional service providers, and specialized vendors, establishing clear expectations and accountability.
• Monitor enrollment, study progress, quality, budgets, and critical operational milestones.
• Identify program risks and lead mitigation, escalation, and corrective-action planning.
• Ensure studies are conducted in accordance with protocols, ICH-GCP, regulatory requirements, and company procedures.
• Partner with Clinical Development, Regulatory Affairs, Biometrics, Pharmacovigilance, Quality, CMC, and other functions to support program execution.
• Contribute to vendor selection, contract negotiations, governance meetings, and performance reviews.
• Support regulatory submissions, inspection readiness, and the continued development of scalable clinical operating processes.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline; an advanced degree is preferred.
• Significant Clinical Operations experience within the biotechnology or pharmaceutical industry.
• Demonstrated success leading global clinical trials across multiple phases of development.
• Experience managing and developing Clinical Operations teams.
• Strong CRO and vendor oversight experience encompassing governance, budgets, contracts, timelines, and performance management.
• Comprehensive knowledge of ICH-GCP, global regulatory requirements, and clinical quality standards.
• Strong operational judgment with the ability to anticipate risks, resolve complex challenges, and maintain program momentum.
• Effective leadership and communication skills within cross-functional and matrixed organizations.
• Sponsor-side experience within oncology, hematology, rare disease, cell therapy, or gene therapy is strongly preferred.
• Ability to work within a hybrid structure in San Diego.

Why Consider This Opportunity?

• Innovative science: Support the advancement of differentiated cell and gene therapy programs addressing serious diseases.
• Delivery ownership: Lead global studies from strategic planning through critical operational milestones.
• Portfolio exposure: Contribute across clinical programs involving emerging therapeutic technologies.
• Leadership impact: Develop clinical operations talent and strengthen the organization’s execution capabilities.
• Partner influence: Establish productive, accountable relationships with CROs and specialized vendors.

Interested?

Submit your resume to Brio to learn more about the organization, its clinical portfolio, and the position. Additional details regarding compensation, benefits, and the complete job description will be provided following an initial resume review.

Brio Resource Group partners with emerging and high-growth life sciences companies to recruit executives, functional leaders, and specialized professionals.